Model Number 1221-36-154 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191); Unspecified Musculoskeletal problem (4535)
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Event Date 08/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the primary tha was on (b)(6) 2016 by dr.(b)(6) at (b)(6).Revision tha was on (b)(6) 2016 by dr.(b)(6) at (b)(6) (head and liner revised, acetabular screw removed).The patient came to the orthopedic urgent care located in dr.(b)(6) clinic complaining of pain.X-rays revealed what appeared to be a failure at the interface of the acetabular shell and poly liner.If accurate, this would be the second such dissociation for this patient since the original surgery in 2016.The poly and head were revised in 2018 for the same indication.The patient is adamant that this is a failure on the part of depuy and has indicated that she will be seeking legal remedy against depuy.Revision surgery is indicated and will be performed by dr.(b)(6) (date to be determined).The patient has indicated that her preference would be that no depuy products are to be used in the revision.Please bring this to the attention of legal.3rd revision.Doi: (b)(6) 2018; dor: (b)(6) 2019, left hip.
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).No code available use for device revision or replacement.
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Event Description
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Pfs alleged weakness.After review of medical records, it was indicated that the patient notice squeaking in her hip.Radiographs were obtained revealing that the acetabular liner had dislodged.The patient was then revised to addressed recurrent failure of left total hip arthroplasty with recurrent disassociation of acetabular polyethylene liner.Operative notes indicated small amount of black metallic staining in the synovium and soft tissue and scar tissue was removed.The ceramic femoral head showed evidence of significant wear and scratching from the acetabular component.The liner was deformed in an oblong elongated manner.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Event Description
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Medical records were received and stated the following: on (b)(6) 2019, the patient had a left total hip revision to address the recurrent failure of the left hip with recurrent dissociation of the acetabular polyethylene liner.Preoperative radiographs revealed an asymmetric position of the femoral head within the acetabulum consistent with dissociation of the poly liner.Prior to surgery, the patient experienced pain, limping, clicking, and weakness in the left hip.During the procedure, the surgeon observed a small amount of black metallic staining in the synovium of the soft tissue, and the liner had disassociated from the cup.The ceramic femoral head showed evidence of significant wear and scratching from the acetabular component.The acetabular cup, liner, and femoral head were revised.Competitor acetabular components along with depuy ceramic femoral head were implanted during this procedure.
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.An x-ray review was performed and confirmed the reported allegation.The investigation found the head and cup component making direct contact suggesting the liner has disassociated form the cup.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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