MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA PARTIAL KNEE FEMORAL CEMENTED COMPONENT SIZE 3 LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices - persona partial knee tibial component cemented size f left medial catalog #: 42538000601 lot #: 64039053, persona partial knee articular surface left medial size f 11mm catalog #: 42518200611 lot #: 63802772, refobacin plus bone cement catalog #: 4720502083-3 lot #: 837da09200.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it is not available.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2021-00003, 0001825034-2021-00346.Investigation incomplete.

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.

Event Description

No further event information available at the time of this report.

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 0001825034-2021-00924.

• Brand Name: PERSONA PARTIAL KNEE FEMORAL CEMENTED COMPONENT SIZE 3 LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11276189
• MDR Text Key: 230221354
• Report Number: 3007963827-2021-00025
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)281231(10)64234164
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000301
• Device Lot Number: 64234164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 109