MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 tibial insert was worn.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that during a knee arthroplasty, the tibial insert would not seat on the tibial tray.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: ARTICULAR SURFACE SIZE EF 12 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13307151
• Report Number: 0001822565-2022-00130
• Device Sequence Number: 3284387
• Product Code: JWH
• UDI-Device Identifier: 00889024211957
• UDI-Public: (01)00889024211957(17)260731(10)64064414
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596404012
• Device Lot Number: 64064414
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 05/03/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/22/2022; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2018
• 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
• Patient Sex: Unknown