Model Number 9627-34-000 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Joint Laxity (4526); Physical Asymmetry (4573)
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Event Date 02/16/2023 |
Event Type
Injury
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Event Description
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Revised a thr of c-stem and marathon cemented cup from approximately 20 years ago.Original surgeon was dr and the operation was at qeii jubilee hospital.Primary reason for revision was for instability/loosening of the cup.Once the pt was open and dislocated the surgeon removed the head from the stem.28mm metal head +3 with 9/10 taper, the head appeared to have minimal wear.Due to limited space and access to the acetabulum the surgeon decided to remove the stem.Once removed the stem appeared to have minimal wear with nil signs of damage.Size 3 ? std.The cement mantle for the stem remained in tack and was happy to keep it for new amt c-stem.The surgeon then removed the marathon cemented cup.Cup removed with cement attached to cup, with minimal obvious wear.Unsure of cup size as not visible on rim.Surgeon then implanted a hybrid zimmer acetabular cup and liner.The surgeon downsized the stem for new cement mantle and adjustment of version of the stem.Size 2 ho c-stem amt.Ceramic 36mm +1.5mm head implanted.Good stability and improved leg length discrepancy.
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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 that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch 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 complaint was not returned.Photo evidence provided was reviewed and found insufficient evidence to identify a device non-conformance.Possible extraction damage is visible.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code/lot code combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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Event Description
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Additional information received indicated that the cement used was not a depuy cement.Primary reason for revision was for instability/loosening of the cup.The surgeon then removed the marathon cemented cup.Cup removed with cement attached to cup, with minimal obvious wear.Affected side was the left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.Photo evidence provided was reviewed and found insufficient evidence to identify a device non-conformance.Possible extraction damage is visible.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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Search Alerts/Recalls
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