MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10 : 42532006402 - tibia cemented 5 degree stemmed right size c - 66382601.G2 : foreign country : japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a total knee arthroplasty was performed and the first articular surface didn't mate with tibial plate although the surgeon confirmed no intervention of cement particles, soft tissue, or bone spurs between the surface and the tibial plate.He inserted the surface with the inserter many times, however, the surface moved back to the front.A second poly of the same size was tried with the same tibial plate, but the same problem occurred.As a result, the operation was completed with a smaller poly.There was a 16-30 minute delay.The surgical technique was utilized.Attempts have been made and all available information has been provided.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING
• 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: 19155431
• MDR Text Key: 341494288
• Report Number: 3007963827-2024-00134
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024241596
• UDI-Public: (01)00889024241596(17)260504(10)65011395
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172524
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522000414
• Device Lot Number: 65011395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2021
• 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
• Patient Sex: Prefer Not To Disclose