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Model Number N/A |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: medical products and therapy date.Detail of product: item # 00877504001, item name biolox delta hd 12/14 40x-3.5, lot # 2948866.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.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 during revision surgery the surgeon couldn't manage to remove the ceramic head on the stem.He had to remove the stem as well to remove the head.
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Manufacturer Narrative
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Investigation results were made available.Dhr review: ref#: 01.06010.003; lot#: 2942684.Yield: 39.Delivered: 38.Scrapped: 1 parts scrapped due to the plate to machine the thread was calibrated wrong.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#: 00-8755-040-01; lot#: 2948866.Yield: 99.Delivered: 99.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 : jammed.Event description: it was reported that during the revision surgery surgeon was unable to remove the biolox delta head (ref: 00-8775-040-01) from the avenir müller stem (ref: 01.06010.003).Therefore he had to remove the stem as well as the head.The reason of the revision surgery was due to migration of the maxera cup 7 days after the primary op.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.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.Review of inspection pan.Review of surgical technique.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).Products were not returned for detailed examination.Inspection plans of the devices confirm that the respective characteristics were inspected thoroughly.Therefore, it can be excluded that a manufacturing error favored or contributed to the reported event of seized implants.It is possible that an uncleaned surface of the stem taper might have led to being stuck of the head on the stem.However, without the products to examine it is not possible to find a root cause of the reported failure.Based on the given information the complaint could not be confirmed and we were not able to identify a specific root cause for this issue.However, the risk of difficulty in removing the head from the stem is covered in the risk management work-sheet.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).Note: the following case is associated with this incident (same patient): (b)(4).The following reports are associated with this event: 0009613350-2019-00113-1.
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Event Description
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Investigation results are now available.
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Search Alerts/Recalls
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