Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)
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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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An article/literature was received entitled "increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ update 18 sep 2019.¿increased serum ion levels after ceramic-on-metal bearing total hip arthroplasty: influence of an asian lifestyle¿ was reviewed for mdr reportability.The study followed 404 primary total hip arthroplasties, including 258 ceramic-on-metal (com tha) and 146 ceramic-on-ceramic or ceramic-on-polyethylene (non-com tha).A pinnacle acetabular cup and summit cementless stem were used in both groups.The ceramic-on-metal operations used biolox delta modular head and ultamet liner while the non-ceramic-on-metal operations used a depuy head with either a depuy ceramic liner or marathon polyethylene liner.It is noted specific patient identifiers nor specific revision information was provided.The following adverse events were noted: dislocation occurred in 5 com tha and 2 non-com tha.All dislocations were corrected with closed reduction with no reported recurrence.1 com tha patient complained of a noisy hip with no evidence of intervention.1 com tha patient underwent a revision to address a pseudotumor.Multiple patients in each group developed elevated metal ion levels.There is no evidence of revision or intervention to address elevated levels.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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