Model Number N/A |
Device Problems
Naturally Worn (2988); Migration (4003)
|
Patient Problems
Pain (1994); Swelling (2091)
|
Event Date 05/26/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: item (b)(4), lot: 63777152; item (b)(4), lot: 63563611.Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient received a total knee arthroplasty and approximately one year after the procedure the patient experienced pain and swelling and was revised two years after the initial procedure due to dislodge and poly wear.Attempts have been made and no further information has been received.
|
|
Event Description
|
It was reported that the patient received a total knee arthroplasty and approximately one year after the procedure the patient experienced pain and swelling and was revised two years after the initial procedure due to dislodge and poly wear.It was noted significant findings of a compartmental arthroplasty with joint space loss of the medial compartment and inferior depression of the tibial.Attempts have been made and no further information has been received.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02001.
|
|
Manufacturer Narrative
|
(b)(4).Visual evaluation of the returned products found the articular surface to exhibit damage in the proximal and distal surfaces (nicked / gouged / wear / discoloration) and the locking features.Visual examination of the returned product confirmed implant wear.Unable to confirm articular surface disassociation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided and reviewed by a health care professional.Review found joint space loss of the medial compartment and inferior depression of the tibial plateau component (subsidence), resulting in genu varus.Overall bone quality appears normal.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|