MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISASSEMBLY BODY

Catalog Number	297500700
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
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
It was reported that the patient had dislocated hip and was brought to or for open reduction.Stem seemed to not have enough antiversion when relocated and checked for stability.Head was removed, liner removed, set screw removed and proximal body disassociated by provided instrumentation.Trial reduction repeated and stability was significantly improved with more version.Proximal bod reimplanted along with new liner and head.After case, the removal device was badly to be separated although it functioned as expected intraoperatively.It will be returned.No instruments were broken operatively.No surgical delay.
Additional Manufacturer Narrative
Investigation summary: the instrument associated with this report was not returned.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 DISASSEMBLY BODY
• Common Device Name: DISASSEMBLY BODY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7112496
• Report Number: 1818910-2017-51479
• Device Sequence Number: 781195
• Product Code: LXH
• UDI-Device Identifier: 10603295156062
• UDI-Public: 10603295156062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 297500700
• Device Lot Number: J1010
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 57