MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX TRIAL SHAFT 85; RECLAIM INSTRUMENTS : FEMORAL TRIALS

Model Number 2975-29-085

Device Problem Break (1069)

Patient Problems Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  Injury  

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 internal screw of the femoral trial broke into two parts.There was a 20 minute surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected b3, h1 and h6 (health effect - clinical and impact codes.

Event Description

It was also reported that due to a broken test component inside the instruments, dislocation problems occurred at the end of the surgery.Faced with this problem, the surgeon decided to replace the head and insert.

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.

• Brand Name: RECLAIM PROX TRIAL SHAFT 85
• Type of Device: RECLAIM INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12273750
• MDR Text Key: 264937747
• Report Number: 1818910-2021-16948
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295156277
• UDI-Public: 10603295156277
• 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,Followup
• Report Date: 07/15/2021

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: 2975-29-085
• Device Catalogue Number: 297529085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 10/06/2021
• Supplement Dates FDA Received: 08/11/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1