MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE F 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number	42-5282-006-10
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: partial tibial cemented size f right medial: catalog#42538000602, lot#64087092.Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial partial knee arthroplasty, the articular surface would not seat with the tibial tray.A second bearing was used and the procedure was completed without complication.There was no surgical delay nor patient impact.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The investigation is in progress.Upon completion of the investigation or receipt of additional information, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned articular surface exhibits damage to the locking feature.Damage includes being nicked or gouged and a crack in the locking feature on the medial/anterior location.The locking feature is nicked, gouged and compressed.Shows that the locking features are compressed.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to use error.Detailed instructions for inserting the articular surface are provided in the associated surgical technique.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it with the inserter instrument.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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
No further event information at time of this report.

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE F 10 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: 15432387
• Report Number: 0001825034-2022-02151
• Device Sequence Number: 5673664
• Product Code: HSX
• UDI-Device Identifier: 00880304818378
• UDI-Public: (01)00880304818378(17)221231(10)63887333
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161592
• 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): 02/02/2023

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: 12/31/2022
• Device Model Number: 42-5282-006-10
• Device Catalogue Number: 42528200610
• Device Lot Number: 63887333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 02/01/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 09/27/2022; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose