MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB CR TRL SZ 5 12MM; TIBIAL TRIALS

Model Number 2545-05-220

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that the cement in groove cannot be removed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was returned for analysis.Visual analysis revealed that one of the tabs was found chipped.No foreign substances were observed, therefore the report allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: ATTUNE FB CR TRL SZ 5 12MM
• Type of Device: TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16589387
• MDR Text Key: 311740543
• Report Number: 1818910-2023-06313
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295479444
• UDI-Public: 10603295479444
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2545-05-220
• Device Catalogue Number: 254505220
• Device Lot Number: BFA239V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1