MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; 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  

Manufacturer Narrative

(b)(4).H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the device was discovered to have missing components.Attempts to obtain additional information have been made; however, no more is available.

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/provided pictures identified signs of use.The returned shim was missing a ball bearing.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.This device is confirmed to have been a part of a capa investigation.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.Complaint is confirmed based on the product evaluation.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
• 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: 17644331
• MDR Text Key: 322205598
• Report Number: 0001822565-2023-02316
• Device Sequence Number: 1
• Product Code: MBH
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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: 42527900704
• Device Lot Number: 62215877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: ZFA 2014-67; Z-1052-2015
• Patient Sequence Number: 1