MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRVD 32+13; FEMORAL TRIALS

Model Number 2530-94-000

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the instruments were worn and no longer usable.The slap hammer was used during surgery and found to be broken and not usable.There was no impact on surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will bereviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.Corrected: h6 (medical device problem code).

• Brand Name: ARTIC/EZE TR BALL GRVD 32+13
• Type of Device: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12235101
• MDR Text Key: 264125622
• Report Number: 1818910-2021-16189
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295129028
• UDI-Public: 10603295129028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2530-94-000
• Device Catalogue Number: 253094000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1