| Model Number N/A |
| Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Unspecified Infection (1930); Pain (1994); Reaction (2414)
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| Event Date 07/15/2019 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: m2a-magnum recap cup 54odx48id catalog #:157854 lot #:2206560.An additional mdr report was filed for this event, please see associated report: 3002806535 -2019 -00527.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the patient's legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure is being planned due to pain and elevated metal ion levels.
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Event Description
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It was reported by the patient's legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure is being planned due to pain and elevated metal ion levels.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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(b)(4).It has been reported the possibility of increased higher levels but this has not been confirmed.Revision is scheduled, however the date is not confirmed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported by the patient's legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure is being planned due to pain and elevated metal ion levels.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported by the patient's legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure is being planned due to pain and elevated metal ion levels.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.D11: medical product: m2a-magnum recap cup 54odx48id, catalog #: 157854, lot #: 2206560.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00527-4.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Ref: x-ray review: twenty radiographs have been provided with (b)(4) for analysis.Five x-rays taken prior to the primary surgery ((b)(6) 2012) and eight x-rays taken after the revision surgery ((b)(6) 2019) were not evaluated in this assessment.Three anteroposterior (ap) post-primary x-rays ((b)(6) 2012) have been provided: implant components appear adequately sized; however, it is not possible to measure the inclination angle of the acetabular cup because no x-ray shows the full pelvis and therefore they do not show the necessary bony landmarks to determine the inclination angle of the acetabular component.Four ap pre-revision x-rays ((b)(6) 2018 ¿ (b)(6) 2019) have been provided: implant components appear adequately sized, and the inclination angle of the acetabular shell was measured to be 45.5° in the full-pelvis x-ray taken on (b)(6) 2018 and 45.8° in the full pelvis x-ray taken on (b)(6) 2019 (closest date to revision surgery), in agreement with the inclination angle of 45° recommended in the surgical technique for the recap hip resurfacing system.The anteversion angle cannot be measured with the available radiographs.Surgical notes from the primary surgery ((b)(6) 2012) state that a mcminn resurfacing was performed after a diagnosis of osteoarthritis with lateralisation in left hip.These were particularly difficult operating conditions with a technically complex implant and muscle forces.In particular, there was oedematous, inflamed, swollen synovitis with considerable capsular thickening and a flexion contracture.Surgical notes from the revision surgery ((b)(6) 2019) indicate that this was performed after a diagnosis of metal wear and extensive liquid seam following a mcminn resurfacing procedure on the left hip.These were particularly difficult operating conditions with extensive fluid retention and absolutely firmly seated mcminn prosthesis.The surgical notes further mention that following a single positive result and a single negative result for the aspirated fluid, the implant would be replaced in a single session.It is unclear whether the statement about positive/negative results refers to presence of infection.Upon opening of the joint, there was an extensive, enlarged bursa with a dark-coloured, but ultimately clear, effusion.The joint mucosa was reddened without appearing infected.Furthermore, samples were taken for histology and bacteriology.Samples from the capsule and acetabular floor were also sent for histology and bacteriology ¿ at the time of writing this report, no information pertaining to such investigations has been provided.It was further noted in the surgical notes from revision surgery that the hip resurfacing head appeared completely normal, with a shiny surface and was absolutely firm, although an intraoperative naked eye observation cannot be used as definite evidence of the condition of the head.The acetabular shell was absolutely firmly seated.Upon removal of the shell, the acetabular floor showed no osteolyses (sic) and no indication of an infection nor metal wear with alval tumour.Although the complaint description states that the hip resurfacing device was revised due to pain and elevated metal ion levels, no data of blood metal ion levels was provided for analysis at the time of writing this report.The instructions for use for the recap hip resurfacing system [2] state that: -biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals, they cannot be expected to withstand the same activity levels and loads of normal healthy bone and joint tissue.-elevated metal ion levels have been reported with metal-on-metal articulating surfaces.The potential long term biological effects of metal wear debris and metal ion production are not known.Patient warnings: -the patient is to be cautioned to govern activities, protecting the joint replacement from unreasonable stress conditions.Excessive activity, failure to control body weight and trauma affecting the joint replacement have been associated with premature failure of the reconstruction by loosening, fracture and/or wear of the implants.Possible adverse events: -material sensitivity reactions.Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts.The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process.Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.An association had been reported between articulating surfaces of: i) cocrmo alloy on cocrmo alloy, ii) cocrmo alloy on polyethylene, and iii) titanium alloy on polyethylene in hip replacements and increased genotoxicity.-however the clinical relevance of the data is not known and no definite conclusions were drawn as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data.It was also noted that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from hip replacement.-wear and/or deformation of articulating surfaces.-metal-on-metal articulating surfaces have limited clinical history.Although mechanical testing demonstrates that metal-on-metal articulating surfaces provide relatively low amounts of particles, the total amount of particulate matter produced remains undetermined.Elevated metal ion levels have been reported with metal-on-metal articulating surfaces.Because of the limited clinical and preclinical experience, the long-term biological effects of the particulate matter and metal ions are unknown.-aseptic lymphocyte-dominated vasculitis associated lesion (alval).-effusion: the root cause that led to implant revision cannot be determined without post-primary full-pelvis x-rays, as well as patient information such as age, weight, height and activity level.Results of blood and synovial fluid tests, histopathology and bacterial testing are required for a complete analysis.Furthermore, analysis of the explants is required to determine the root cause of the event reported.The manufacturing history records (mhrs) for the recap/magnum acetabular shell and the recap resurfacing femoral head have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 2 years has found no similar complaints reported with these item 157854 and 157248.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: -line 1 to line 4 relate to the reported event ¿ toxicity.-the highest severity score for these lines is 4.Premature revision (as reported in this event) is considered to have a severity score of 3.-therefore, the reported event is in line with the risk file.No corrective or preventive actions are deemed necessary at this time.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.
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Event Description
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It was reported by the patient's legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure was performed on (b)(6) 2019 due to pain and elevated metal ion levels.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Event Description
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Information received on 03-jun-2019: initial letter received from the patient legal representative that the patient suffered from pain due to hip implants (metal on metal combination).Additional information received on 28-aug-2019: it was reported by the patient legal representative, that the patient underwent an initial left hip replacement procedure.Subsequently, a revision procedure was performed on (b)(6) 2019 due to pain and elevated metal ion levels.Additional information received on june 03, 2020: following the receipt of the first preliminary review conducted by outside counsel, a medical expert was requested to conduct a detailed review.The main conclusions are: the alleged elevated metal ion levels and metalosis are not documented in the patient medical file; the patient suffered from an infection which was established by means of tissue examinations taken during the revision surgery.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.G3: report source, foreign - event occurred germany.Multiple mdr reports were filed for this event, please see associated reports:3002806535-2019-00527-5.This final/ follow-up report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, a medical review conducted on 03 june 2020 states infection established by means of tissue examinations.A review of sterilisation certificates confirm that the products received radiation within the specified standard range.The x-ray review was carried out prior to an infection being confirmed.This information would not have aided the x-ray review as an infection would not be evident on a radiograph.X-ray review: twenty radiographs have been provided with (b)(4) for analysis.Five x-rays taken prior to the primary surgery ((b)(6) 2012) and eight x-rays taken after the revision surgery ((b)(6) 2019) were not evaluated in this assessment.Three anteroposterior (ap) post-primary x-rays (((b)(6) 2012) have been provided: implant components appear adequately sized; however, it is not possible to measure the inclination angle of the acetabular cup because no x-ray shows the full pelvis and therefore they do not show the necessary bony landmarks to determine the inclination angle of the acetabular component.Four ap pre-revision x-rays (((b)(6) 2019) have been provided: implant components appear adequately sized, and the inclination angle of the acetabular shell was measured in the full-pelvis x-ray taken on ((b)(6)2018 and 45.8 in the full-pelvis x-ray taken on ((b)(6) 2019 (closest date to revision surgery), in agreement with the inclination angle of 45° recommended in the surgical technique for the recap hip resurfacing system [1].The anteversion angle cannot be measured with the available radiographs.Surgical notes from the primary surgery (((b)(6) 2012) state that a mcminn resurfacing was performed after a diagnosis of osteoarthritis with lateralisation in left hip.These were particularly difficult operating conditions with a technically complex implant and muscle forces.In particular, there was oedematous, inflamed, swollen synovitis with considerable capsular thickening and a flexion contracture.Surgical notes from the revision surgery (((b)(6) 2019) indicate that this was performed after a diagnosis of metal wear and extensive liquid seam following a mcminn resurfacing procedure on the left hip.These were particularly difficult operating conditions with extensive fluid retention and absolutely firmly seated mcminn prosthesis.The surgical notes further mention that following a single positive result and a single negative result for the aspirated fluid, the implant would be replaced in a single session.It is unclear whether the statement about positive/negative results refers to presence of infection.Upon opening of the joint, there was an extensive, enlarged bursa with a dark-coloured, but ultimately clear, effusion.The joint mucosa was reddened without appearing infected.Furthermore, samples were taken for histology and bacteriology.Samples from the capsule and acetabular floor were also sent for histology and bacteriology ¿ at the time of writing this report, no information pertaining to such investigations has been provided.It was further noted in the surgical notes from revision surgery that the hip resurfacing head appeared completely normal, with a shiny surface and was absolutely firm, although an intraoperative naked eye observation cannot be used as definite evidence of the condition of the head.The acetabular shell was absolutely firmly seated.Upon removal of the shell, the acetabular floor showed no osteolyses (sic) and no indication of an infection nor metal wear with alval tumour.Although the complaint description states that the hip resurfacing device was revised due to pain and elevated metal ion levels, no data of blood metal ion levels was provided for analysis at the time of writing this report.Additional information received on june 03, 2020: following the receipt of the first preliminary review conducted by outside counsel, a medical expert was requested to conduct a detailed review.As part of the claims handlings process the main conclusions are: the alleged elevated metal ion levels and metalosis are not documented in the patient medical file; the patient suffered from an infection which was established by means of tissue examinations taken during the revision surgery.Ifu 5401000219-recap-rev 6 : recap total hip resurfacing system.The instructions for use for the recap hip resurfacing system state that: biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals, they cannot be expected to withstand the same activity levels and loads of normal healthy bone and joint tissue.Elevated metal ion levels have been reported with metal-on-metal articulating surfaces.The potential long term biological effects of metal wear debris and metal ion production are not known.Patient warnings: the patient is to be cautioned to govern activities, protecting the joint replacement from unreasonable stress conditions.Excessive activity, failure to control body weight and trauma affecting the joint replacement have been associated with premature failure of the reconstruction by loosening, fracture and/or wear of the implants.Possible adverse effects: material sensitivity reactions.Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts.The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process.Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.An association had been reported between articulating surfaces of: i) cocrmo alloy on cocrmo alloy, ii) cocrmo alloy on polyethylene, and iii) titanium alloy on polyethylene in hip replacements and increased genotoxicity.However the clinical relevance of the data is not known and no definite conclusions were drawn as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data.It was also noted that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from hip replacement.Wear and/or deformation of articulating surfaces.Metal-on-metal articulating surfaces have limited clinical history.Although mechanical testing demonstrates that metal-on-metal articulating surfaces provide relatively low amounts of particles, the total amount of particulate matter produced remains undetermined.Elevated metal ion levels have been reported with metal-on-metal articulating surfaces.Because of the limited clinical and preclinical experience, the long-term biological effects of the particulate matter and metal ions are unknown.Aseptic lymphocyte-dominated vasculitis associated lesion (alval).Effusion.Early or late postoperative infection and allergic reaction.The root cause that led to implant revision cannot be determined without post-primary full-pelvis x-rays, as well as patient information such as age, weight, height and activity level.Furthermore, analysis of the explants is required to determine the root cause of the event reported.The manufacturing history records (mhrs) for the recap/magnum acetabular shell and the recap resurfacing femoral head have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 2 years has found no similar complaints reported with these item 157854 and 157248.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.The reported event states revision due to pain.In the risk file, pain is considered harm with a severity level of 4 for a number of hazards.Bqs 408 (current at the time the rmr was written) defines a severity score of 4 as: mechanical failure resulting in total loss of function; failure of procedure necessitating immediate revision of further procedure; total loss of patient activity or function; severe or chronic pain; injury to user or theatre staff; severe tissue reaction from materials or wear / corrosion products; loss of sterility.Therefore, the reported event is in line with the risk file.The reported event also states revision due to elevated metal ion levels.In the risk file, the most appropriate line is line 1 to 4 (toxicity), which has a severity of 4.Bqs 408 (current at the time the rmr was written) defines a severity score of 4 as: mechanical failure resulting in total loss of function; failure of procedure necessitating immediate revision of further procedure; total loss of patient activity or function; severe or chronic pain; injury to user or theatre staff; severe tissue reaction from materials or wear / corrosion products; loss of sterility.The medical review conducted on 03 june 2020 also states infection established by means of tissue examinations.In the file, the most appropriate lines are 5 to 7 (infection), which has a severity of 4.Bqs 408 (current at the time the rmr was written) defines a severity score of 4 as: mechanical failure leading to impairment or function; failure of procedure leading to premature revision or further procedure; severe loss of patient activity or function; moderate pain; moderate tissue reaction to materials or wear / corrosion products.Therefore, the reported event is in line with the risk file.The outcome of the reported event (surgical intervention and pain) therefore is in line with the rmf.The m2a recap/magnum acetabular shells and the recap resurfacing heads (under uk design control) have not been manufactured in any of biomet global manufacturing facilities since september 2014 due to changing market demands and production planning reasons.Biomet continues to maintain residual stock of the m2a magnum system, which is manufactured by biomet uk ltd and by biomet orthopedics llc.Up to incl.September 2014, and the recap resurfacing head, which is manufactured by biomet uk ltd, at its european distribution centre in the netherlands until it is fully consumed.This stock is maintained, because biomet is contractually obliged to maintain stock of these mom devices to comply with on-going tender commitments.Sales data is showing (b)(4) items sold from july 2016 through to november 2018.Potential risks associated with mom devices are indeed widely reported in literature and acknowledged by the orthopedic society, but it an evolving area which requires further research.Patient and surgical factors play a role.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert 5401000219 lists under possible adverse effects: improper selection, placement, positioning and fixation of the implant components, may result in unusual stress conditions which may lead to subsequent reduction in service life of the implants.Malalignment of the implants or inaccurate implantation can lead to excessive wear and/or failure of the implants or procedure.Inadequate removal of surgical debris prior to closure of the wound can lead to excessive wear.Improper preoperative or intraoperative handling of the implants causing damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear.
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