MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number 42-5221-003-11

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) d10: medical product: tibia cemented 5 degree stemmed right size c: catalog#42532006402, lot#65481553.G2: foreign: japan customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty.During the procedure, the surgeon was unable to mate the articular surface with the tibial plate despite multiple attempts.There was a surgical delay of less than thirty (30) minutes however no patient impact or adverse events have been reported as a result of the malfunction.The procedure was successfully completed with a second articular surface without further complication.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual inspection of the return product identified the distal surface to exhibit damage with the locking features flared out.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.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 Description

No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 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: 17164826
• MDR Text Key: 317825421
• Report Number: 3007963827-2023-00170
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5221-003-11
• Device Catalogue Number: 42522100311
• Device Lot Number: 65421535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose