MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 12 MM THICKNESS; 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 Date 03/02/2023

Event Type  malfunction  

Event Description

It was reported that a tasp shim was missing ball bearings.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, 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 is being submitted to relay additional information.Visual examination of the returned product found it to exhibit signs of repeated use and have one or both of components disassembled / missing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 12 MM THICKNESS
• 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: 16631843
• MDR Text Key: 312203600
• Report Number: 0001822565-2023-00861
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024245761
• UDI-Public: (01)00889024245761(10)65102477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 42527900302
• Device Lot Number: 65102477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1