MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISTAL TAPERED 16X190; HIP FEMORAL STEM

Catalog Number 197616190

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

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

Der states during total hip revision, the distal tapered stem was implanted and proximal reaming was performed with protective sleeve on stem.When it came time to remove sleeve it would not remove.The surgeon started to break off the sleeve but it would not remove.The surgeon started to break off the sleeve, then removed the stem to remove the sleeve.This was a huge issue since reimplantation of stem was impacted further than previous position.Surgical delay: 10 mins.

Manufacturer Narrative

(b)(4).Investigation summary
=
> no device associated with this report was received for examination.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM DISTAL TAPERED 16X190
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7128471
• MDR Text Key: 95333075
• Report Number: 1818910-2017-52003
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295077046
• UDI-Public: 10603295077046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102080
• 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: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 197616190
• Device Lot Number: C51238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR