The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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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This follow-up report is being filled to relay investigation result.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: could not be performed as the item number is unknown event description: it was reported by the therapeutic goods administration (tga) that the australian orthopaedic association national joint replacement registry (aoanjrr) has registered a higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty.The reason for revision surgery is unknown, but could however be one of the following: dislocation, infection, loosening, fracture and pain.Review of received data: data extract from the aoanjrr received for the higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty providing data such as: average duration of implantation, implant catalog ranges, reason for revision surgeries and years of which the products were revised.Device 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 could not be performed as the complete product information is not known.Conclusion: it was reported by the therapeutic goods administration (tga) that the australian orthopaedic association national joint replacement registry (aoanjrr) has registered a higher than expected revision rate for a combination of avenir stem / fitmore cup used for total hip arthroplasty.The reason for revision surgery is unknown, but could however be one of the following: dislocation, infection, loosening, fracture and pain.Neither product identification, x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.It is only known that there was a revision surgery either due to one of the following events: dislocation, infection, loosening, fracture or pain.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.Issue evaluation has been initiated on 24.10.2019 as per management request to further address this outlier report.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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