MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED FEMUR SIZE 4 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona partial knee articular surface right medial size e 8mm catalog #: 42528200508, lot #: 63583930, persona partial knee cemented tibia size e right medial catalog #: 42538000502, lot #: 63881381.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records could 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 oct 15, 2019, oct 31, 2019 and mar 24, 2020 under manufacturing report number 0001822565-2019-04430.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2019-00295, 0001825034-2020-01310, 0001825034-2020-01315.
Event or Problem Description
It was reported that approximately 1 year post implantation, the patient was treated for pain and instability.Initial operative notes did not identify any intraoperative complications.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED FEMUR SIZE 4 RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9879974
• Report Number: 0001825034-2020-01310
• Device Sequence Number: 561243
• Product Code: HSX
• UDI-Device Identifier: 00880304808553
• UDI-Public: (01)00880304808553
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000402
• Device Lot Number: 63532896
• 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: 03/23/2020
• Initial Report FDA Received Date: 03/25/2020
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 109