MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BEARING (AS) 71 MM WIDTH 14 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Joint effusion (4849)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00271; 0001825034-2024-00272; 0001825034-2024-00273.D10-medical product vanguard cr ilok fem-rt 65 item# 183008 lot# j6917396 series a pat std 25 3 peg item# 184760 lot# 807800 biomet cc cruciate tray 71mm item# 141233 lot# j6869986 bone screw self-tapping 6.5 mm dia.25 mm length item# 0062500652lot# 64611734 qty: (b)(4) biomet bc r 1x40 us item# 110035368 lot# f2701z12ba qty: (b)(4).H3- customer has indicated that the product will not 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 a patient was revised approximately two years and four months post implantation due to pain, instability, effusions, and patella impingement with malalignment.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that this item was reported under the wrong mfr.
Event or Problem Description
Upon receipt of additional information, it was determined that this item was reported under the wrong mfr.

• Brand Name: TIBIAL BEARING (AS) 71 MM WIDTH 14 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18623302
• Report Number: 0001825034-2024-00270
• Device Sequence Number: 18003313
• Product Code: JWH
• UDI-Device Identifier: 00889024564534
• UDI-Public: (01)00889024564534(17)240930(10)64469192
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: VE189064
• Device Lot Number: 64469192
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American