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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 304791130
• Report Number: 3007963827-2022-00304
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468894
• UDI-Public: (01)00889024468894(17)250430(10)64666785
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 57 KG