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Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: maxim stemmed tibial bearing catalog # 141513 lot # 239110, ti maxim 65 const rt intlk fem catalog # cp110278 lot # 367080, biomet ilok stem tib tray 71mm catalog # 141513 lot # 239110, bmt splined knee stm 14x80 catalog # 141614 lot # 384710, arcom rnglc lnr 22mm 10deg 22 catalog # 11-105842 lot # 135260.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-02792.Remains implanted.
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Event Description
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It was reported that the patient underwent a right total knee arthroplasty.Subsequently, the patient is experiencing pain and disassociation of the implant post-operative.
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Manufacturer Narrative
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(b)(4).Upon reassessment of the reported event, it was determined to not be reportable, as this device did not cause or contribute to the event.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient underwent right knee arthroplasty revision due to pain and disassociation of the polyethylene bearing.Only the polyethylene bearing was removed and replaced.Revision operative notes were received that indicate the patient was revised due to the screw migrating to the knuckle of the tibial polyethylene liner and irritating the other implants, resulting in metallosis.The femoral, tibial and patellar implants were well fixed and only the polyethylene articular surface and screw were removed and replaced.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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It is unknown which stem the disassociated screw was packaged with.It could be one of the following: biomet splined knee stem 14mm x 80mm item #: 141614 lot #: 384710.Manufacture date: may 8, 2002; sterile expiration date: may 31, 2012.Biomet splined knee stem 18mm x 80mm item #: 141618 lot #: 051600.Manufacture date: aug 22, 2001; sterile expiration date: aug 31, 2011.The complaint sample was evaluated and the reported event was confirmed through physical evaluation and review of medical records.The returned tibial bearing and femoral stem post screw showed that the post screw was embedded in the tibial bearing and the threads on the posterior side of the screw had been worn down, likely from articulation on the femur after disassociation.Black staining could be seen on the tibial bearing and the articulating surfaces showed evidence of delamination and wear.The post where the screw was embedded was severely damaged.The device history records were reviewed and no discrepancies were identified.The revision operative notes identified significant black staining of the synovial soft tissues and some of the bone with a small area of wear along the patellar component.The femoral, tibial and patellar component were all well-fixed and the screw was locked in to the post of the tibial polyethylene liner.The metallosis found in the joint was likely the result of the disassociated screw articulating with the femur in vivo.Due to the damage sustained by the screw in vivo, further analysis could not be performed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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