MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL COMPONENT CEMENTED SIZE F LEFT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant 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 product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.This report was previously submitted erroneously on jan 5, 2021 and feb 3, 2021 under manufacturing report number 3007963827-2021-00003.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2021-00346.0001825034-2021-00924.
Event or Problem 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.

• Brand Name: PERSONA PARTIAL KNEE TIBIAL COMPONENT CEMENTED SIZE F LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11586045
• Report Number: 0001825034-2021-00923
• Device Sequence Number: 17338843
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• UDI-Public: (01)00880304812703(17)280831(10)64039053
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 64039053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 109