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

Catalog Number	197616190
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > no device associated with this report was received for examination.
Additional 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
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7128471
• Report Number: 1818910-2017-52003
• Device Sequence Number: 19255106
• Product Code: KWA
• UDI-Device Identifier: 10603295077046
• UDI-Public: 10603295077046
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 197616190
• Device Lot Number: C51238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017; 01/22/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/22/2018; 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR