MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 9 HI OFFSET; HIP FEMORAL STEM

Catalog Number	101214090
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/23/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Revision due to mechanical loosening of the depuy stem.Bone to implant loosening interface.Medical records have been reviewed.Primary procedure notes (b)(6) 2013 indicate the patient received a right hip conversion to total hip arthroplasty, anterior approach, due to right hip avascular necrosis.Procedure was completed without complication indicated by the surgeon.Revision notes (b)(6) 2014 indicate the patient received a revision total hip arthroplasty due to mechanical loosening, right total hip.The surgeon indicated that the stem was visualized and there were no clear signs of loosening, fibrous tissue was removed and an extractor was used to dislodge the stem.Post-op diagnosis does indicate mechanical loosening.Procedure was completed without complication indicated by the surgeon.
Additional Manufacturer Narrative
(b)(4) no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 9 HI OFFSET
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7108332
• Report Number: 1818910-2017-51354
• Device Sequence Number: 13720499
• Product Code: KWA
• UDI-Device Identifier: 10603295001119
• UDI-Public: 10603295001119
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2017

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: 101214090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 04/25/2018; 07/13/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 04/25/2018; 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 141