MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign source: japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient underwent a left knee revision approximately 1 moth post implantation due to pain and tibial subsidence.Attempts have been made and no further information has been provided.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
• 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: 15659294
• Report Number: 0001822565-2022-03043
• Device Sequence Number: 14923259
• Product Code: MBH
• UDI-Device Identifier: 00889024510555
• UDI-Public: (01)00889024510555(17)320129(10)65261926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 10/24/2022

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: 42530007101
• Device Lot Number: 65261926
• 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: 10/03/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose