ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 44¸ 38, CODE D; DUROM ACETABULAR COMPONENT
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cyst(s) (1800)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 a revision surgery due to voluminous pseudotumor from hip debris right.
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Manufacturer Narrative
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Investigation results were made available.Additional: h2, h6.Event description: it was reported that patient was experiencing voluminous pseudotumor from right hip and debris.Review of received data: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Pictures, x-rays (if applicable): no evaluation of the pictures/x-rays as the reported event is already known and addressed in cp00000620.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Device purpose: this device is intended for treatment.Product evaluation: visual examination: no product was returned for visual examination.Conclusion 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/wear).Most likely root cause for the reported event is inappropriate use/implantation of the product.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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Event Description
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Investigation has been completed.
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