MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX NECK TRL 40MM; RECLAIM INSTRUMENTS : FEMORAL TRIALS

Catalog Number 297531040

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 12/03/2018

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 during a revision hip the neck segment (2975-31-040 was stuck and would not move.It was during our second trialing that this happened.The surgeon decided to trial after the real implant was in place.This cause a 30 second delay.There were no pieces lost and everything was recovered from the case.Surgical delay of 30 seconds.

Manufacturer Narrative

Product complaint # : (b)(4).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 PROX NECK TRL 40MM
• Type of Device: RECLAIM INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8204118
• MDR Text Key: 131709346
• Report Number: 1818910-2018-79422
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295156369
• UDI-Public: 10603295156369
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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: 297531040
• Device Lot Number: SO2001362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1