Catalog Number 136532720 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Date 12/14/2021 |
Event Type
Injury
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Event Description
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It was reported that the surgeon stated that his patient was hearing squeaky noise coming from her hip.After an x-ray was taken he noticed that the head ball was malposition.Patient was revised with dual mobility.Chart notes and x-rays to follow.It was also indicated that there was malposition of the cup.Doi: (b)(6) 2019 - dor: dec 14,2021 (unknown side).Mrr findings, aei note a-10291640 under (b)(4).On (b)(6) 2022, the patient had a revision right total hip to address fractured, dislocated, deformed polyethylene liner, metallosis in surrounding tissue.Head and liner were revised.
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 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: according to the information received, ¿it was reported that the surgeon stated that his patient was hearing squeaky noise coming from her hip.After an x-ray was taken he noticed that the head ball was malposition.Patient was revised with dual mobility.Chart notes and x-rays to follow.It was also indicated that there was malposition of the cup.Doi: (b)(6) 2019 - dor: (b)(6) 2021 (unknown side)".The product and photos ((b)(4) x-ray films ad (b)(6) 2022) were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Review of the returned dlt ts cer hd 12/14 32mm +5 could confirm a disassociation event since it was found that occurred a transfer of the titanium cup material onto the surface of the ceramic head.This is a result of the femoral head having articulating against the inner surface of the cup post disassociation of the liner.This evidence of material transfer is expected in cases of disassociation and does not indicate any error or device defect regarding the femoral head.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner disassociation and does not signify any product error.However, based on the available information no signs a dislocation between the femoral head and liner were observed.The overall complaint was confirmed as the observed condition of the dlt ts cer hd 12/14 32mm +5 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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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