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| Model Number N/A |
| Device Problem
Appropriate Term/Code Not Available (3191)
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| Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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Event Description
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Patient was implanted on the right side and is being monitored due to pain, decreased range of motion.
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Manufacturer Narrative
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Concomitant medical products: item# 01.04555.120, lot# 2707103, sidus stem-free shoulder, humeral anchor, uncemented, m.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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No change to previously reported event.
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Manufacturer Narrative
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This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: pain and reduced range of motion event description: it was reported that the patient was implanted with sidus implants on (b)(6) 2013 the patient reported continued pain affecting daily living at 1, 3, and 5 year visits with decreased range of motion and difficulty with adl (activities of daily living).The patient takes place in the crf study sidus_e1201 with patient id 7.Medical history of patient includes post-traumatic avascular necrosis of the right shoulder.Review of received data: surgical report of implantation, dated (b)(6) 2013.Surgeon: prof.Dr.(b)(6).Institution: (b)(4).Diagnosis: post-traumatic humeral head necrosis condition after open reposition, plate osteosynthesis, arthrolysis and ie procedure: implantation of a humeral head endoprosthesis typ sidus, right description of procedure: luxation of the humeral head.Resection of the humeral head at the anatomical neck.Massive sclerotic alteration.Size determination of the head.Head size 44 shows a good fit.Insertion of a kirschner wire, reaming of the metaphysis and pre-impaction with the impactor.Attention towards the glenoid.After reposition sclerotic alteration.Extensive cartilage alteration.Therefore, indication for the implantation of a hemiprosthesis.Circular release of the capsule in terms of a 270 arthrolysis.Again luxation of the head.Impaction of the anchor size m.Consequently impaction of the head size 44/16.Removal of the collar-osteophythes and reposition.X-ray control with correct position of the implants.Clear ad axim displacement due to the malposition.Closure.- complaint timeline assessment reviewed by nurse krista harding: the male patient, born 1956 with a bmi of 22.5, takes place in the crf study sidus_e1201 with patient id 7.Initial surgery was on (b)(6) 2013.Medical history opf patient includes post-traumatic avascular necrosis of the right shoulder.Medical findings: - 3 month visit: no pain, no meds, satisfied.- 6 month visit: missed visit.- 1 year visit: moderate pain (8/10), greatly disturbed sleep, decrease in adls, used pain meds, satisfied.- 2 year visit: moderate pain, no meds, satisfied, decrease in rom, continued difficulty with adls - 5 year visit: moderate pain, used pain meds, somewhat satisfied, interrupted sleep, continued difficulty with rom and adls.No medical intervention other than pain medication identified.Crf report for study sidus_e1201e, patient id: (b)(6) generated by (b)(6) date (b)(6) 2013 (implantation): form medication & patient satisfaction - date (b)(6) 2013 (implantation): 1.Does patient take pain/anti-inflammatory meds: yes: non-steroidal anti-inflammatory pain killer (daily).2.Subjective shoulder value (ssv): 20% - form 1 - date (b)(6) 2013 (implantation): 5.Dominant shoulder: right 7.Primary diagnosis: post traumatic focal avascular necrosis - form 2 - date (b)(6) 2013 (implantation): 1.Bone stock humerus: sclerotic, no bone deficiency - form 3a - date (b)(6) 2013 (implantation): 1.Procedure: hemi shoulder replacement 5.Surgical approach: deltopectoral 9.Or time (skin to skin): 105 minutes - form 3b - date (b)(6) 2013 (implantation): operative findings: 1.Deltoid status: normal.2.Rotator cuff: intact.3.Biceps: pathological and tenotomised.4.Bone quality humerus: sclerotic.5.Bone quality glenoid: sclerotic.6.Humeral head resection: freehand.- form 5 - date (b)(6) 2013 (implantation): postoperative radiographic evaluation: 6.Humeral anchor position (a/p view): 139, lateralised.7.Humeral head: correctly positioned.- form 6 - date (b)(6) 2013 (implantation): 1.Range of motion - forward elevation: 31-60.2.Range of motion - lateral elevation: 31-60.3.Range of motion - external rotation: unable to perform any of the functions listed below.4.Range of motion - internal rotation: dorsum of hand to buttock.6.Pain: 12/16 (moderate-severe).7.A.Percentage of desired daily work: 0-20%.7.B.Percentage of desired recreation/sport: 81-100% (full recreation/sport).7.C.Patient's sleep was: unaffected.8.Patient can move hand: up to xiphoid (sternum).- form 7a - date (b)(6) 2013 (implantation): 2.Range of motion: forward elevation (active/passive): 45/50.2.Range of motion: external rotation (active/passive): 25/25.- form 7b - date (b)(6) 2013 (implantation): no instability registered.Overall pain score 7.5 out of 10.Date (b)(6) 2013 (3 month visit): - form medication & patient satisfaction - date (b)(6) 2013 3 month visit): 1.Does patient take pain/anti-inflammatory meds: no.2.Subjective shoulder value (ssv): 90%.- form 7b - date (b)(6) 2013 (3 month visit): no instability registered.Overall pain score 0 out of 10.- form 11a & b - date (b)(6) 2013 (3 month visit): a/p view: humerus.1.Radiolucency (mm): none.2.Osteolysis (mm): none axillary view: humerus.5.Radiolucency (mm): none.6.Osteolysis (mm): none.- form 15 - date (b)(6) 2015.Date (b)(6) 2015 (6 months visit): patient missed follow-up visit.Date (b)(6) 2014 (1 year visit): - form medication & patient satisfaction - date (b)(6) 2014 (1 year visit): 1.Does patient take pain/anti-inflammatory meds: yes: non-narcotic analgesics (daily) 2.Subjective shoulder value (ssv): 25% - form 6 - date (b)(6) 2014 (1 year visit): 1.Range of motion - forward elevation: 61-90.2.Range of motion - lateral elevation: 61-90.3.Range of motion - external rotation: hand behind head, with elbow forward.4.Range of motion - internal rotation: dorsum of hand to buttock.6.Pain: 11/16 (moderate).7.A.Percentage of desired daily work: 21-40%.7.B.Percentage of desired recreation/sport: 0-20%.7.C.Patient's sleep was: greatly disturbed.8.Patient can move hand: up to neck.- form 7a - date nov 13, 2014 (1 year visit): 2.Range of motion: forward elevation (active/passive): 70/70.2.Range of motion: external rotation (active/passive): 5/40.- form 7b - date (b)(6) 2014 (1 year visit): no instability registered.Overall pain score 8 out of 10.- form 11a & b - date (b)(6) 2014 (1 year visit): a/p view: humerus.1.Radiolucency (mm): none.2.Osteolysis (mm): none.Axillary view: humerus.5.Radiolucency (mm): none.6.Osteolysis (mm): none.Date (b)(6) 2016 (2 year visit): - form medication & patient satisfaction - date (b)(6) 2016 (2 year visit): 1.Does patient take pain/anti-inflammatory meds: no 2.Subjective shoulder value (ssv): 30% - form 6 - date (b)(6) 2016 (2 year visit): 1.Range of motion - forward elevation: 61-90.2.Range of motion - lateral elevation: 61-90.3.Range of motion - external rotation: unable to perform any of the functions listed below.4.Range of motion - internal rotation: dorsum of hand to buttock 6.Pain: 09/16 (mild-moderate).7.A.Percentage of desired daily work: 21-40%.7.B.Percentage of desired recreation/sport: 21-40%.7.C.Patient's sleep was: interrupted.8.Patient can move hand: up to neck.- form 7a - date (b)(6) 2016 (2 year visit): 2.Range of motion: forward elevation (active/passive): 80/90.2.Range of motion: external rotation (active/passive): 10/15.- form 7b - date (b)(6) 2016 (2 year visit): no instability registered.Overall pain score 5 out of 10.- form 11a & b - date (b)(6) 2016 (2 year visit): a/p view: humerus.1.Radiolucency (mm): none.2.Osteolysis (mm): none.Axillary view: humerus.5.Radiolucency (mm): none.6.Osteolysis (mm): none.Date (b)(6) 2018 (5 year visit): - form medication & patient satisfaction - date (b)(6) 2018 (5 year visit): 1.Does patient take pain/anti-inflammatory meds: yes: non-narcotic analgesics (weekly) 2.Subjective shoulder value (ssv): 30% - form 6 - date (b)(6) 2018(5 year visit): 1.Range of motion - forward elevation: 61-90.2.Range of motion - lateral elevation: 61-90.3.Range of motion - external rotation: unable to perform any of the functions listed below.4.Range of motion - internal rotation: dorsum of hand to buttock.6.Pain: 09/16 (mild-moderate) 7.A.Percentage of desired daily work: 21-40%.7.B.Percentage of desired recreation/sport: 21-40%.7.C.Patient's sleep was: interrupted.8.Patient can move hand: up to neck.- form 7a - date (b)(6) 2018(5 year visit): 2.Range of motion: forward elevation (active/passive): 80/80.2.Range of motion: external rotation (active/passive): - - form 7b - date (b)(6) 2018 (5 year visit):.No instability registered.Overall pain score 5.5 out of 10.Device analysis: no product was returned to zimmer biomet for in-depth analysis as the devices remain implanted.Review of product documentation: the product combination was approved by zimmer biomet.Conclusion: it was reported that the patient was implanted with sidus implants on (b)(6) 2013 the patient reported continued pain affecting daily living at 1, 3, and 5 year visits with decreased range of motion and difficulty with adl (activities of daily living).The patient takes place in the crf study sidus_e1201 with patient id 7.Medical history of patient includes post-traumatic avascular necrosis of the right shoulder.Review of the surgical notes showed that the patient suffered of a post-traumatic humeral head necrosis condition after open reposition, plate osteosynthesis, arthrolysis and ie.The surgical notes revealed massive sclerotic alteration on the humeral head.Additionally, also the glenoid showed sclerotic alteration and extensive cartilage alteration, which led to the implantation of a hemiprosthesis.After the pre-operative performed arthrolysis, a circular release of the capsule in terms of a 270° arthrolysis was performed intraoperatively.The final x-ray control showed correct position of the implants.However, a clear ad axim displacement due to the previous trauma is mentioned as well.The study notes report patient visits at the day of implantation and the follow-up visits at 3 months, 1 year and at 5 years post implantation.The patient missed the 6 months' visit.Review of the study notes in terms of usage of pain killers and pain score showed that over the course of the 5 years' post-op the patient experienced a dramatic improvement in pain 3 months after the surgery, followed by a worsening until 1-year post-op, followed by a slight improvement until 2 years' post-op at which level the pain remained until 5 years post-op.Regarding the range of motion, the patient experienced an improvement regarding forward and lateral elevation.However, the external and internal rotation could not be improved by the surgery.The x-ray assessment did not show any radiolucency, osteolysis, atrophy nor any hypertrophy over the first two years post-op.No assessment was reported for the 5-year visit.Additionally, the shoulder was never reported to suffer from instability over the 5 years of follow-up.The review clearly showed that the patient must have experienced a heavy trauma, which also influences the outcome of the implantation in regards to implant fit, positioning and restoration of the joint biomechanics.No x-rays were received, therefore, the implant positioning could not be evaluated.However, the study reports mention a good implant fit, with respect to the patient's pre-op condition.Further, the review of the received documents did not reveal any indication for a device related factor that is in direct relation to the pain and the limited range of motion that the patient experienced.Further, the quality records showed that all specified characteristics have met the specifications valid at the time of production.Therefore, we assume the patient's comorbidity due to the post-traumatic avascular necrosis as the most likely root cause for the reported course of events.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Please refer to report.
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Manufacturer Narrative
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This follow-up report is being filled to relay investigation updated result.Review of received data (in addition): x-ray analysis: summary of imaging: ap and axillary views of the right shoulder labeled 3 month, 1 year, 2 year and 5 year.Assessment of imaging: right shoulder surface replacement arthroplasty has been performed.On all sets of images, the alignment is maintained without subluxation or dislocation.There are no fractures.The bones are osteopenic on all images.The 3 month images show no abnormality.The 1 year images show minimal new lucency at the superior bone-metal interface consistent with osteolysis.The 2 year images show further interval increase in size of this small focus of osteolysis.The 5 year images show minimal further increase in size of the area of osteolysis.There is no evidence of component loosening on any images.Small focus of osteolysis at the superior bone-metal interface of the humeral surface arthroplasty implant as noted.Overall fit and alignment are anatomic.Bone quality on all images is osteopenic.There is progressive radiolucency along the superior bone-metal interface of the humeral implant reflecting osteolysis as described.There is no radiographic evidence of loosening or wear.There is no malalignment.Patient anatomy is unremarkable but the bones are osteopenic.There is progressive osteolysis as noted.No subsidence, subluxation, or corrosion is present.Conclusion (updated): it was reported that the patient was implanted with sidus implants on (b)(6) 2013.The patient reported continued pain affecting daily living at 1, 3, and 5 year visits with decreased range of motion and difficulty with adl (activities of daily living).The patient takes place in the crf study sidus_e1201 with patient id 7.Medical history of patient includes post-traumatic avascular necrosis of the right shoulder.Review of the surgical notes showed that the patient suffered of a post-traumatic humeral head necrosis condition after open reposition, plate osteosynthesis, arthrolysis and ie.The surgical notes revealed massive sclerotic alteration on the humeral head.Additionally, also the glenoid showed sclerotic alteration and extensive cartilage alteration, which led to the implantation of a hemiprosthesis.After the pre-operative performed arthrolysis, a circular release of the capsule in terms of a 270° arthrolysis was performed intraoperatively.The final x-ray control showed correct position of the implants.However, a clear ad axim displacement due to the previous trauma is mentioned as well.The study notes report patient visits at the day of implantation and the follow-up visits at 3 months, 1 year and at 5 years post implantation.The patient missed the 6 months' visit.Review of the study notes in terms of usage of pain killers and pain score showed that over the course of the 5 years' post-op the patient experienced a dramatic improvement in pain 3 months after the surgery, followed by a worsening until 1-year post-op, followed by a slight improvement until 2 years' post-op at which level the pain remained until 5 years post-op.Regarding the range of motion, the patient experienced an improvement regarding forward and lateral elevation.However, the external and internal rotation could not be improved by the surgery.The x-ray assessment did not show any radiolucency, osteolysis, atrophy nor any hypertrophy over the first two years post-op.The 5-year follow up showed radiolucency and osteolysis of 4 mm, but no atrophy and no hypertrophy.The shoulder was never reported to suffer from instability over the 5 years of follow-up.The review clearly showed that the patient must have experienced a heavy trauma, which also influences the outcome of the implantation in regards to implant fit, positioning and restoration of the joint biomechanics.The received x-rays show progressive radiolucency along the superior bone-metal interface of the humeral implant reflecting osteolysis.There is no radiographic evidence of loosening or wear.There is no malalignment.The patient anatomy was found to be unremarkable but the bones are osteopenic.These findings correlate with the study reports that mention a good implant fit, with respect to the patient's pre-op condition.Further, the review of the received documents did not reveal any indication for a device related factor that is in direct relation to the pain and the limited range of motion that the patient experienced.Further, the quality records showed that all specified characteristics have met the specifications valid at the time of production.Therefore, we assume the patient's comorbidity due to the post-traumatic avascular necrosis as the most likely root cause for the reported course of events.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Please refer to 0009613350-2018-01282.
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Event Description
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Please refer to report 0009613350-2018-01282.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Corrected information are filled in the following fields: correction: b4 - g4 - g7 - h2 - h10.Review of received data.- form 7b - date nov 15, 2018 (5 year visit): no instability registered.Overall pain score 5.5 out of 10, updated by (b)(6) to 5.0 (see dl1029973) - form 11a & b - date nov 15, 2018 (5 year visit), form added by (b)(6) (see dl1029973): a/p view: humerus.1.Radiolucency (mm): 4 mm (zone 1).2.Osteolysis (mm): 4 mm (zone 1).Axillary view: humerus.5.Radiolucency (mm): none.6.Osteolysis (mm): none.Conclusion summary.It was reported that the patient was implanted with sidus implants on (b)(6) 2013.The patient reported continued pain affecting daily living at 1, 3, and 5 year visits with decreased range of motion and difficulty with adl (activities of daily living).The patient takes place in the crf study sidus_e1201 with patient id 7.Medical history of patient includes post-traumatic avascular necrosis of the right shoulder.Review of the surgical notes showed that the patient suffered of a post-traumatic humeral head necrosis condition after open reposition, plate osteosynthesis, arthrolysis and ie.The surgical notes revealed massive sclerotic alteration on the humeral head.Additionally, also the glenoid showed sclerotic alteration and extensive cartilage alteration, which led to the implantation of a hemiprosthesis.After the pre-operative performed arthrolysis, a circular release of the capsule in terms of a 270° arthrolysis was performed intraoperatively.The final x-ray control showed correct position of the implants.However, a clear ad axim displacement due to the previous trauma is mentioned as well.The study notes report patient visits at the day of implantation and the follow-up visits at 3 months, 1 year and at 5 years post implantation.The patient missed the 6 months' visit.Review of the study notes in terms of usage of pain killers and pain score showed that over the course of the 5 years' post-op the patient experienced a dramatic improvement in pain 3 months after the surgery, followed by a worsening until 1-year post-op, followed by a slight improvement until 2 years' post-op at which level the pain remained until 5 years post-op.Regarding the range of motion, the patient experienced an improvement regarding forward and lateral elevation.However, the external and internal rotation could not be improved by the surgery.The x-ray assessment did not show any radiolucency, osteolysis, atrophy nor any hypertrophy over the first two years post-op.The 5-year follow up showed radiolucency and osteolysis of 4 mm, but no atrophy and no hypertrophy.The shoulder was never reported to suffer from instability over the 5 years of follow-up.The review clearly showed that the patient must have experienced a heavy trauma, which also influences the outcome of the implantation in regards to implant fit, positioning and restoration of the joint biomechanics.No x-rays were received, therefore, the implant positioning and the mentioned radiolucency and osteolysis could not be evaluated.However, the study reports mention a good implant fit, with respect to the patient's pre-op condition.Further, the review of the received documents did not reveal any indication for a device related factor that is in direct relation to the pain and the limited range of motion that the patient experienced.Further, the quality records showed that all specified characteristics have met the specifications valid at the time of production.Therefore, we assume the patient's comorbidity due to the post-traumatic avascular necrosis as the most likely root cause for the reported course of events.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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