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Manufacturer narrative: the reason for this revision surgery was due to impingement of neck to metal collar.The previous surgery and the revision detailed in this investigation occurred 16.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Note, there was discrepant material report (dmr) associated with the reported component.Receiver control number (b)(4), purchase order number (b)(4) discrepant material report-(b)(4).Nine (9) units rejected for: detail z deviation 40 degrees typical (typ), specification requirements 45 degrees +/- 1 degree.Disposition-use as is.Deviation wil not adversely affect function.Vendor to correct form tool error.Component met all required specifications when released from manufacturing.This issue could not have contributed to the incident reported.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to impingement of neck to metal collar.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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The reason for this revision surgery was due to impingement of neck to metal collar.The previous surgery and the revision detailed in this investigation occurred 16.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to impingement of neck to metal collar.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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Manufacturer narrative: the reason for this revision surgery was due to impingement of neck to metal collar.The previous surgery and the revision detailed in this investigation occurred 16.8 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The surgeon elected to keep the components, so they were not returned for investigation.No photographs were provided of the reported condition, so it could not be confirmed.A dhr (device history record) review was conducted: part/number: 498-00-050, lot: 671191, cup al-al flared rim 50 millimeter, revision m quantity: 8, was batched from subcomponent lots: part/number: 498-00-050, lot: 36403, cup al-al flared rim 50 millimeter revision m quantity.9, received 01-mar-2000 with one discrepant material report.The 45+/-1 degree angle of the liner-mating snap feature was reported as 40 degrees on all pieces.The parts were accepted with the justification deviation will not adversely affect function.Vendor to correct form tool error.This was approved by manufacturing engineering, design engineering and quality control.This discrepancy could not have contributed to the failure mode of impingement.All components met design and manufacturing specifications when released from manufacturing at djo surgical, with the exception of the liner-mating snap feature of the cup.No deficiency in that mating relationship is reported.All components were within sterilization at the time of implantation.No other complaints have been received against this lot number.There are no remaining items from this lot in inventory because this part has been obsolesced.This complaint reports impingement between the neck and the raised rim of the cup.In the design history file, the design requirement document indicates that encore orthopedics received clearance to market the keramos system in november 2003.Since the original date of surgery for this complaint precedes the date of market clearance it can be concluded that this original surgery was a part of the clinical trial, (preliminary design/device protocol) pdp-d980003 that is reviewed in the section of the design requirement document entitled "ceramic/ceramic lip removal" dated (b)(6) 2004.This study review indicates that the purpose of the peripheral rim of the cup was to protect the ceramic insert from impingement at extreme ranges of motion to reduce the possibility of chipping leading to brittle fracture of the insert.The analysis concludes that the components included in this complaint (50 millimeter shell and +3.5 millimeter head) may be susceptible to impingement of the stem on the rim of the cup at a 118-degree arc of motion.A review of the study cohort led to the conclusion that "it appears as if the peripheral rim was added to the acetabular cup to (1) address a problem that has a low probability of occurring and (2) has no impact on acetabular insert integrity should it occur." the recommendation was that the rim be removed to improve range of motion.There was a single documented case during the study of impingement between the stem and cup resulting in metal debris in the joint.This was not considered a significant concern for patient safety because "ti alloy debris will not result in negative tissue reaction." however, it was considered preferable to eliminate the potential for this stem/cup impingement.In 2003, a similar shell design was released to production without a raised rim (430-01-048/066).Historical sales data indicates that 1320 units of the al-al (rimmed) shell family (498-00-048/066) were sold between 1998 and 2005.No sales of the rimmed cup are documented after 2005.While the analysis acknowledges the potential for titanium debris in the joint, it does not mention cobalt chrome.However, the keramos system was sold for use with existing encore hip stems, including foundation, revelation, linear and vitality hip systems.This patient received a cobalt chrome stem from the foundation 460 hip series.These decisions were made in the late 1990s, well before the wear of cobalt chrome was identified as a potential cause of metallosis.The patient had revision surgery after nearly 17 years of use.This distribution of the shell with the peripheral rim was limited to the study participants.Subsequent to the study and the above-referenced analysis, this shell was removed from service and replaced with a design that minimized impingement for broader market distribution.The keramos ceramic-on-ceramic system is no longer offered for sale due to changing market demands, driven by the availability of newer polyethylene liners with improved wear properties.This incident does not represent a negative quality trend or an increase in patient risk that requires action.The root cause of this event is impingement leading to excessive wear and metallosis.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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