(b)(4).
Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00486.
Concomitant medical devices: articular surface use with plate 3,4 size yellow/c-h 10 mm height, catalog#: 00595203010, lot#: 62066380; stemmed tibial component, catalog#: 00598003702, lot#: 62031439; stem extension replacement screw, catalog#: 00598009000, lot#: 62062312; taper stem plug, catalog#: 00596009900, lot#: 62036569; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; all poly patella size 32 mm dia.
Standard 8.
5 mm thickness, catalog#: 00597206532, lot#: 62087178.
Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.
The investigation is in process.
Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that patient underwent left total knee arthroplasty.
Subsequently, the patient was revised due to stiffness, pain, swelling, numbness, and audible noise.
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