Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Foreign Body Reaction (1868); Local Reaction (2035)
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Event Date 04/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: item# unknown, lot# unknown, durom cup hip implant; item# unknown, lot# unknown, cls stem hip implant.Premarket identification: this product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states under 510(k) number k053536.Device evaluated by manufacturer: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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).Device discarded by hospital.
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Event Description
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It was reported that the patient had a revision surgery due to metallosis.Attempts to obtain additional information have been made; however, no more has been provided.
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Manufacturer Narrative
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The manufacturer did not receive devices or x-rays for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations.As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required.The durom cup reported in this case is not marketed in the usa.A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008.No further investigation required as this issue is known and addressed in cp00000620 (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Therefore, zimmer gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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Please refer to report 0009613350-2019-00308.
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Search Alerts/Recalls
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