MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*SLEEVE PRX ZTT, 16F-LRG; HIP FEMORAL STEM/SLEEVE

Catalog Number	550516
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/31/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Litigation papers allege pain, decreased range of motion, and elevated metal ion levels.Update - (b)(6) 2014 - plaintiff¿s fact sheet was received, which identified part/lot information from patient sticker sheet.The complaint and associated mdrs were updated.Complaint was updated on (b)(6) 2014.Update (b)(6) 2017: medical records received.Updated the product details.Added the taper sleeve adaptor, proximal sleeve and the stem for the alleged elevated metal ion levels.There is no revision note and laboratory values provided.This complaint was updated on: (b)(6) 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7192870
• Report Number: 1818910-2018-10049
• Device Sequence Number: 19304907
• Product Code: LPH
• UDI-Device Identifier: 10603295175261
• UDI-Public: 10603295175261
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550516
• Device Lot Number: 1038449
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR