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Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 05/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Age: (b)(6).Concomitant medical products: femur cemented cruciate retaining (cr) catalog # 42502605801 lot # 62477299, articular surface fixed bearing ultracongruent catalog # 42511200511 lot # 62361821.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01536, 0001822565-2019-01538.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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It is reported the patient underwent a left total knee arthroplasty and subsequently fifteen months after the procedure the patient experienced radiolucency of the tibial and femoral components.As well as pain, difficulty ambulating, difficulty using stairs, catching, clicking noise, swelling, stiffness, loosening, limited or decrease in activity of daily living and heterotopic ossification of the femur and patella.The patient further notes that the knee never feels "normal" and the knee feels like it will give away.
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Manufacturer Narrative
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(b)(4).Articular surface fixed bearing ultracongruent catalog # 42511200511 lot # 62361851.
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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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Manufacturer Narrative
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(b)(4).D4: udi # (b)(4).Complaint confirmed with crf report.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were reviewed and found the patient experienced pain, difficult ambulating, difficult with adls, swelling, clicking, and stiffness.Radiographs assessment identified radiolucency of the tibial and femoral components.Radiographs assessment also identified heterotopic ossification near femur and patella.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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