Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Swelling (2091); Osteolysis (2377)
|
Event Date 10/27/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices - persona partial knee femoral component cemented size 3 left catalog #: 42558000301 lot #: 64234164, persona partial knee articular surface left medial size f 11mm catalog #: 42518200611 lot #: 63082772, unknown refobacin cement catalog #: ni lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will 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.Investigation incomplete.
|
|
Event Description
|
It was reported that the patient underwent a left knee arthroplasty revision to address tibial osteolysis and pain approximately fifteen (15) months post-operatively.Attempts have been made and no additional information is available at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2021-00003, 3007963827-2021-00025, 0001825034-2021-00346.
|
|
Event Description
|
It was reported that the patient underwent a left knee arthroplasty revision to address pain, swelling and tibial osteolysis approximately fifteen (15) months post-operatively.Initial operative notes did not identify any intraoperative complications.Revision operative notes reported removal of implants without bone loss with no loosening identified.New components were implanted and the surgery was completed without complications.Attempts have been made and no additional information is available at this time.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001825034-2021-00923.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|