Model Number N/A |
Device Problems
Material Erosion (1214); Naturally Worn (2988)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 11/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown which devices were explanted during the revision surgery.00801803601 femoral head sterile product do not resterilize 12/14 taper 60884562 multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2024 - 00033.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that the patient had an initial left total hip arthroplasty.Subsequently, the patient underwent a first revision surgery two (2) years post implantation due to acetabular loosening; during which, a new metal shell, metal head, and poly liner was placed.Subsequently, the patient had a second revision fourteen (14) years post implantation due to pain, wear, and metallosis.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)-stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified no additional complaints for the stem.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had an initial left tha with no complications noted.The first revision occurred due to cup loosening; no complications were noted.Medical records were not provided for the second revision that occurred; however, it was indicated in the legal claim that a revision occurred to remove the metal-on-metal products within the scope of a recall due to pain, wear, and metallosis.No other information was provided.This complaint cannot be confirmed.Medical records were not provided for the second revision, only the legal claim.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.D10: 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells 60912574.00620205422 shell porous with cluster holes 54 mm 60868099.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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