MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEM UPPER PULL ROD; HIP INSTRUMENT

Catalog Number 297500635

Device Problems Bent (1059); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

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

It was reported that the distal stem inserter may not have been fully engaged within the distal stem implant during the insertion of the implant, possibly damaging the threaded portion of the implant.Later, the pull rod portion of the assembly tool would not thread into the distal stem implant properly; therefore, the tensile bar did not break into two pieces during the tensioning of the tapers of the proximal body implant and the distal stem implants.The locking bolt was locked into place no difficulty.The threads of the pull rod appeared to be damaged (bent) during a visual inspection of the instrumentation.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy 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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7068853
• MDR Text Key: 93443642
• Report Number: 1818910-2017-50408
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2017

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 Catalogue Number: 297500635
• Device Lot Number: SO2023196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 07/30/2018
• Supplement Dates FDA Received: 12/13/2017; 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1