MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE (MC) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the bearing would not lock into the tibia.There was a visible gap at the anterior portion of the tibia base plate.A second bearing was used with the same results.The second bearing could not be removed from the tibia base plate.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).D10-medical product.Tibia cemented 5 degree stemmed right size f item# (b)(4).Lot# 66459991 unknown persona articular surface g2- australia 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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
It was reported during the initial total knee arthroplasty, the bearing would not lock into the tibia.There was a visible gap at the anterior portion of the tibia base plate.There was an additional ten to fifteen minutes of surgical time added on to this case due to this issue.The second poly did not get stuck into the original tibial tray.The second poly was only ever inserted into the second tibial base plate.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified that the articular surface remains assembled with the tibia.Product exhibits signs of use (tool marks) and the articular surface doesn't appear to be fully seated on the tibial plate.Dimensional analysis of the products determined that the products, where measured, were conforming to print specifications.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is confirmed based on the returned devices showing that the articular surface doesn't appear to be fully seated on the tibial plate.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch 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 (MC) RIGHT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19310001
• Report Number: 3007963827-2024-00177
• Device Sequence Number: 6911133
• Product Code: MBH
• UDI-Device Identifier: 00889024468337
• UDI-Public: (01)00889024468337(17)280229(10)65787122
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• 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): 09/06/2024

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 Model Number: N/A
• Device Catalogue Number: 42522100710
• Device Lot Number: 65787122
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 09/05/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/07/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: Male