Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Material Rupture (1546); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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Investigation in progress.Device was discarded by the hospital.
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Event Description
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It was reported that the patient was implanted with tm patella during left tka on (b)(6) 2018.On (b)(6) 2018, it was reported that the patient underwent a revision surgery.Alleged event description mentions, "nexgen tm patella dislodged from single peg hole and fell into the area anterior of the prosthesis(femur & tibial).Patient had to be re-admitted and undergo a revision surgery to remove said patella implant.Patient patella tendon was ruptured".
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Event Description
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Revision due to loosening.
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Manufacturer Narrative
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No device was returned for evaluation, therefore only a device history review was performed.A device history record was reviewed for the tm patella with part number 00587806541 and lot number 63911019, and no deviations or anomalies were found.A review of the implant's manufacturing record indicates that it was manufactured to specification.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Tm patella is the only component that is zimmer tmt design.Should additional information be obtained to further this investigation, this report shall be updated.
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Search Alerts/Recalls
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