MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 18 MM HEIGHT; PROSTHESIS, KNEE

Model Number 42-5121-008-18

Device Problem Difficult to Insert (1316)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that during an initial left total knee arthroplasty, the articular surface would not seat onto the tibial tray during implantation.There was no patient impact and no adverse events have been reported as a result of this malfunction.A second device was used to complete the procedure.

Manufacturer Narrative

Cmp: (b)(4).Medical product: natural tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#65217767.Multiple mdr reports have been filed for this event.Please see associated report: 3007963827-2023-00062.The product will not be returned to zimmer biomet for evaluation, as the product location is unknown.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.However, from the follow up correspondence, it was found that surgeon had difficult in seating the articular surface, so he impacted the articular surface to seat them.A definitive root cause cannot be determined.However, we found that the surgeon deviated from the surgical technique to seat the final as into the tibial plate.Persona personalized alignment total knee arthroplasty surgical technique provides proper seating technique to assemble the articular surface into tibial plate.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.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 18 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: 16618315
• MDR Text Key: 312043031
• Report Number: 3007963827-2023-00061
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469358
• UDI-Public: (01)00889024469358(17)270614(10)65392079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5121-008-18
• Device Catalogue Number: 42512100818
• Device Lot Number: 65392079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• 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
• Patient Sex: Male