ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S,¸ 32/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD
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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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It was reported that patient underwent revision surgery due to squeaking noises.The squeaking started about 4 weeks before revision surgery.
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Event Description
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Investigation results are now available.
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Manufacturer Narrative
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Concomitant medical products : item: biolox delta taper liner, gg 32 item#: 00-8775-008-32 lot#: 2938732 investigation results were made available.Additional: concomitant medical products and if follow-up, what type.Correction: date of report, event, concomitant medical products, and pma/510k.Dhr-review: ref#:(b)(4) lot#: 2935004 - yield: 100 - delivered: 100 the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#:(b)(4) lot#: 2938732 - yield: 108 - delivered: 108 the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: functional : implants squeaking event description: it was reported that the patient had squeaking noises.Product was implanted on (b)(6)2018.And explanted on (b)(6)2019.The squeaking started about 4 weeks before revision surgery.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: - visual examination: ceramic insert: minor secondary metal transfer is observed on the articulating surface.This is probably produced after the revision surgery.Primary metal transfer is seen on the outer surface of the insert at the taper top/center area.This metal transfer is observed in case of a symmetrical taper fit situation between the ceramic insert and the metal shell.However, rather weak metal transfer found on the area of the size engraving "gg/32" compared to the opposite are might be an indication of a very slight unsymmetry of the insert in the metal shell.Metal transfer found on the rim of the insert over the circumference might indicate a possible impingement between the ceramic insert and the metallic stem.Ceramic head: there are metal transfer patterns of erratic appearance on the outer surface, on the face and on the outer chamfer of the ceramic head which are assigned to secondary effects like rubbing with metal parts after or during the revision surgery.In the case of a symmetrical taper fir situation between the ceramic head and the metallic stem taper, thin concentric lines (primary metal transfer) on the taper top region over the whole circumference are expected.These metal transfer patterns can be seen on the conical bore surface.Review of product documentation: all involved devices are intended for treatment.- the compatibility check was performed and showed that the product combination was approved by zimmer biomet.- instruction for use (ifu) for biolox delta heads is reviewed.Noise (ceramic pairings only) is listed as an adverse effect on page 8.- raw material certificate is reviewed and it is confirmed that the material is conforming to the specifications.Root cause analysis: root cause determination using rmw: - noise (including squeaking, grinding, clicking) causes patient dissatisfaction due to implant squeaks or clicks (stripe wear).=> possible, stripe wear can lead to squeaking sound generated in a ceramic on ceramic bearing.- noise (including squeaking, grinding, clicking) causes patient dissatisfaction due to implant squeaks or clicks (stripe wear).=> possible, stripe wear can lead to squeaking sound generated in a ceramic on ceramic bearing.Conclusion summary: review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).No medical data such as x-rays or surgical notes were present for the investigation.Visual examination of the head showed a slight unsymmetrical seating of the insert in the metallic shell and possible impingement of the insert with the stem.That might be a possible cause of the squeaking sound.However, it is not possible to make a certain comment in the absence of the x-rays.Based on the returned product and the given information the complaint could be confirmed, however, a specific root cause for this issue could not be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Detail of product: item # 00877500832, item name bioloxâ® delta ceramic taper liner, size gg / 32 i.D.For use with 48 mm o.D.Size gg shell, lot # 2938732.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Please refer to report 0009613350-2019-00406.
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