Catalog Number UNK HIP ACETABULAR LINER METAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Fall (1848); Fever (1858); Inflammation (1932); Nerve Damage (1979); Pain (1994); Rash (2033); Urticaria (2278); Impaired Healing (2378); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Muscle/Tendon Damage (4532); Physical Asymmetry (4573); Swelling/ Edema (4577)
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Event Date 01/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).D4: 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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Event Description
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Data use agreement included patients implanted with pinnacle cup, pinnacle dual mobility metal liner, and bi-mentum dual mobility liner between (b)(6) 2020 and (b)(6) 2021 identifying a total of 38 patients.There was no mention of femoral head or stem manufacturer.No patients in this cohort experienced intra-operative complications.Three patients experienced mortality all within 1-year of index surgery at an average of 7.6 months, all due to causes unrelated to the device implanted but due to pre-existing medical co-morbidities or having undergone the tha procedure.A total of 18 patients experienced 32 adverse events (table below).No mention of medical or surgical intervention.Two patients experienced reoperation of which both were due to periprosthetic fracture during an acute episode of alcohol intoxication.Blistering/hives 1 (3.1%).Calf cramping 1 (3.1%).Calf swelling 1 (3.1%).Cellulitis 1 (3.1%).Death 3 (9.4%).Delayed wound healing 1 (3.1%).Ed visit 1 (3.1%).Fall 13 (40.6%).Groin pain/catching sensation 1 (3.1%).Gt bursitis 1 (3.1%).It band tendinitis 1 (3.1%).Limb length discrepancy 1 (3.1%).Pain to incision site 1 (3.1%).Postoperative fever 1 (3.1%).Periprosthetic fracture about tha? 2 (6.3%).Sciatica 1 (3.1%).Surgical site drainage 1 (3.1%).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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Search Alerts/Recalls
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