MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36-2; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number 2531-50-000

Device Problem Scratched Material (3020)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

(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

Mdr staff have indicated that several femoral head trials are chewed up and gauged due to wear and tear over an extended period of time.They are no longer functional and require replacements.There was no surgical delay and no patient issues as this was not intra-op.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, 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.

• Brand Name: ARTICUL TR BALL GRVD 36-2
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12069629
• MDR Text Key: 258636916
• Report Number: 1818910-2021-13623
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295129172
• UDI-Public: 10603295129172
• 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: 06/16/2021

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: 2531-50-000
• Device Catalogue Number: 253150000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1