MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN RHK ARTICULAR SURFACE PROVISIONAL SIZE F 12 MM; TEMPLATE

Catalog Number 00588106012

Device Problem Fracture (1260)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: canada visual examination of the returned product identified signs of repeated use (nicked/gouged/wear) and a piece has fractured off the anterior of the distal surface.Not all pieces were returned.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to the wear and tear from repeated use over time.The device has a potential field age of over twenty (20) years and exhibits signs of repeated use.Complaint sample was evaluated and the reported event was confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during an initial total knee arthroplasty, the articular surface trial was found to be cracked.There was no patient impact and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.

• Brand Name: NEXGEN RHK ARTICULAR SURFACE PROVISIONAL SIZE F 12 MM
• Type of Device: TEMPLATE
• 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: 18866558
• MDR Text Key: 337227230
• Report Number: 0001822565-2024-00767
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00588106012
• Device Lot Number: 60033711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose