MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-11 EF TOP; PROSTHESIS, 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).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-00063.Concomitant medical products: tibial articular surface provisional shim size gh 11 mm thickness, item# 42527900701, lot# 62741931.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

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned product found it exhibits signs of repeated use (nicked or gouged) and is fractured on the lateral side of post.All pieces were not returned.Medical records were not provided.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 which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) - provisional top.

Event Description

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

• Brand Name: CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-11 EF TOP
• Type of Device: PROSTHESIS, 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: 16113920
• MDR Text Key: 308095926
• Report Number: 0001822565-2023-00064
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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: 42527600810
• Device Lot Number: 62505567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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