MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument coordinator was checking trays to send out for surgeries and discovered the ball bearings had fallen out of the trial shims.

Event Description

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

Manufacturer Narrative

Received non-capa shim (item # 42527900602 lot # 63368479) and verified item lot combinations and reviewed manufacturing dates as returned shims exhibits signs of repeated use and has both of components 1 and 2 disassembled / missing the missing components were not returned.See attached photos.The device history records for item # 42527900602, lot # 63368479, and & receiving inspection reports for item¿s # 42527950602, lot # 80675309, were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A complaint history search was performed on non-capa lot # 63368479.Review of complaint history identified no/additional similar complaints for the reported item # 42527900602 and lot 63368479 combination.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.Complaint is confirmed.Root cause cannot be determined.

• Brand Name: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10340061
• MDR Text Key: 200863288
• Report Number: 0001822565-2020-02721
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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: 42527900602
• Device Lot Number: 63368479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1