ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE
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Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
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Event Date 03/01/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient was revised approximately nine weeks post implantation due to due to pain, swelling, and possible loosening of the tibial component.During revision, no gross loosening was found in the tibial or femoral components.Mild synovitis was noted.The patella was left intact, all other components were revised without complication.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2022-00133.Concomitant medical products: medical product: femur cemented (ps) narrow right size 6 item# 42500006002, lot# 64472820.Articular surface fixed bearing (ps) right 11 mm height item# 42521400511, lot# 63750891.All poly patella cemented 29 mm diameter item# 42540000029, lot# 64740327.Biomet bc r 1x40 us, item# 110035368, lot# f2701z129ba.Biomet bc r 1x40 us, item# 110035368, lot# f2701z129ba.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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Primary operative notes do not suggest intraoperative complications.Revision operatives notes state that revision was performed due to pain and questionable tibial loosening.Mild synovitis was noted.Neither tibial nor femoral components were grossly loose.Patella left intact, all other components revised without complication.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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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