MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML HIGH OFFSET LG STAT 15.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number	155403150
Medical Device Problem Codes	Corroded (1131); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/07/2016
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
New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege the patient suffers from pain and elevated metal ion levels.Update 8/13/2012 - pfs was received.The part/lot information was identified.There is no new information that would change the outcome of the investigation.Update rec'd 12/07/2016 - the sales rep has reported the revision surgery.Patient was revised to address pain.Complaint updated 12/28/2016.Update oct 18, 2017: medical records received.After review of medical records for mdr reportability, in addition to what was previously reported, patient was also revised to address prosthetic wear and metal on metal reaction.Revision notes reported murky, blood-tinged fluid, brown thickened particulate debris typical for metal on metal reaction, discoloration, black discoloration of the trunion and neck, brown stained reactive tissue, and thickening and discoloration of the synovium.Added stem for the alleged elevated metal ions.This complaint was updated on: oct 26, 2017.
Additional Manufacturer Narrative
New etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege the patient suffers from pain and elevated metal ion levels.The reported event has been evaluated and will be monitored.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: AML HIGH OFFSET LG STAT 15.0MM
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7038958
• Report Number: 1818910-2017-29158
• Device Sequence Number: 11016520
• Product Code: JDI
• UDI-Device Identifier: 10603295058458
• UDI-Public: 10603295058458
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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 Expiration Date: 04/01/2008
• Device Catalogue Number: 155403150
• Device Lot Number: XR3JD1003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR