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

Model Number	42-5121-003-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Approximately two years post-implantation, the patient underwent revision surgery of the tibial component and articular surface.The reason for revision surgery is unknown.Due diligence is in process for this complaint; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Medical product: natural tibia trabecular metal two-peg porous fixed bearing left size c: catalog#42530006401, lot#77007002; tm uncemented femoral component size 5 narrow cr: catalog#ni, lot#ni; unknown short stem extension: catalog#ni, lot#ni; unknown 29mm poly patella: catalog#ni, lot#ni.Report source: foreign: australia.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2022-03352.Customer has indicated that the product will not be returned to zimmer biomet for evaluation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, this device was determined to be not reportable.The patient underwent revision surgery due to tibial subsidence and no allegations were made against the articular surface.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, this device was determined to be not reportable.The patient underwent revision surgery due to tibial subsidence and no allegations were made against the articular surface.The initial report was forwarded in error and should be voided.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 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: 15914814
• Report Number: 3007963827-2022-00304
• Device Sequence Number: 14548923
• Product Code: MBH
• UDI-Device Identifier: 00889024468894
• UDI-Public: (01)00889024468894(17)250430(10)64666785
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 12/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 42-5121-003-10
• Device Catalogue Number: 42512100310
• Device Lot Number: 64666785
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 57 KG