MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM; INSTRUMENT, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported that during sterilization, it was identified that the bearings were missing from the shim.There was no patient involvement, and no additional information to report at this time.

Manufacturer Narrative

(b)(4).G2: canada.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.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19143525
• MDR Text Key: 340685622
• Report Number: 0001822565-2024-01340
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024245754
• UDI-Public: (01)00889024245754(10)64145721
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42527900301
• Device Lot Number: 64145721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose