MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING PS RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	42-5299-001-00
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial left total knee arthroplasty, the articular surface component would not properly seat on the tibial tray.There was no surgical delay or patient impact.The surgery was completed with a second implant without complication.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: tibial articular surface inserter: catalog#: 42529900100, lot#: 65040192; tibia cemented 5 degree stemmed right size e: catalog#: 42532007102, lot#: 65235188.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h10.Upon receiving additional information of the reported event, it was determined that this product did not contribute to the reported event.During the investigation, the associated articular surface inserter was found to be missing a component which was likely the reason for the reported articular surface malfunction.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING PS 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: 14829503
• Report Number: 3007963827-2022-00169
• Device Sequence Number: 2382926
• Product Code: JWH
• UDI-Device Identifier: 00889024246423
• UDI-Public: (01)00889024246423(10)65040192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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 Model Number: 42-5299-001-00
• Device Catalogue Number: 42521400710
• Device Lot Number: 65280394
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Male