ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)
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Event Date 04/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#:00584201502; femoral component high flex precoat lot#: 61975145.Item#:00584202409; articular surface size 4 9 mm height lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01035.0001822565-2020-01033.
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Event Description
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It was reported by patients legal counsel the patient underwent a right unicompartmental knee arthroplasty and was revised approximately 7 years later due to pain, radiolucency, femoral component fracture, loosening, and osteolysis.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 reported event was confirmed by review of photograph and medical records.Visual evaluation of the provided photography confirmed that the femoral implant was fractured.No other visual damage can be noted from the picture.However, the product was not returned for further evaluation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during the initial surgery.Office visits note from (b)(6) 2019, the patient presented with pain, the x-ray found radiolucent line seen on the later view indicating fractured femoral component and loosening of the tibial plate.Bone scan and ct scan found femoral component loosening.The patient had difficulty ambulating and using assist devices for walking.Revision surgery was taken place on (b)(6) 2019.During surgery, the femoral and tibial component was easily removed and the femoral component was grossly loose with extensive osteolysis in the femoral condyle.A definitive root cause cannot be determined.Per package insert, pain, fracture, loosening, and osteolysis are known adverse effects of this system.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Event Description
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No further event information at time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional information provided does not alter previous investigation conclusions.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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