MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY LEFT SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - persona cruciate retaining narrow porous femoral component catalog #: 42502206401 lot #: 65313218, persona medial congruent articular surface left 10mm catalog #: 42512100510 lot #: 64389189.Report source: event occurred in japan.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.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address tibial plate subsidence after a fall and pain approximately one (1) month post-operatively.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being filed to correct information.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address tibial plate subsidence after a fall and pain approximately one (1) month post-operatively.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records received confirmed periprosthetic fracture adjacent to the lateral tibial component with resultant abnormal alignment of the hardware in the proximal tibia and valgus alignment of the knee, which may have been caused by a fall or trauma.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY LEFT SIZE D
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16627118
• Report Number: 0001822565-2023-00781
• Device Sequence Number: 11890215
• Product Code: MBH
• UDI-Device Identifier: 00889024510531
• UDI-Public: (01)00889024510531(17)320723(10)65526113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 42530006701
• Device Lot Number: 65526113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/22/2023; 06/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/12/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Prefer Not To Disclose
• Patient Weight: 78 KG