Concomitant medical products: item: durom us acet cmpnt 48/42 h, catalog #: 01.00214.148, lot #: 2330089; item: metasul ldh, head adapter, s, -4, taper, catalog #: 01.00185.145, lot #: 2365317; item: femoral stem press-fit collarless 12/14, catalog #: 00786401220, lot #: 60629077.As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer (b)(4) (b)(6) legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer (b)(4) never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer (b)(4) as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.Trend analysis: trend has been identified and capa was initiated and performed.Dhr-review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Conclusion: no further investigation required as this issue is known and addressed in (b)(4) (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.(b)(4).The following reports are associated with this event: 0009613350 - 2018 - 00596, 0009613350 - 2018 - 00598.
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A patient is pursuing a product liability claim.It was reported that the patient was implanted with metasul ldh, head, 42, code h, taper 18/20.Approximately 10 years post implantation, the patient underwent revision surgery due to pain, elevated ion levels and loosening.Note: since exact explant date is unknown , first day of the given month ((b)(6) 2017) is taken.
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