MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 6 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214060
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
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 presented with left hip pain and loosening of the stem at the bone to implant interface.The patient had a total hip replacement done at (b)(6) hospital on (b)(6) 2017.The surgeon opened the left hip capsule, sent tissue and fluid specimens to the lab, and continued removing the depuy femoral head, poly liner, and finally, the trilock stem leaving the cup intact, in the acetabulum.The stem showed only a bit of ingrowth and surgeon suspected that to be the cause of the pain.The lab reports came back negative for infection.The surgeon implanted a new competitor stem, a new depuy poly liner and competitor femoral head, washed the joint out with copious amounts of antibiotic saline irrigation, and after one last range-of-motion exercise, closed the wound.To recap: no infection, suspected loose trilock stem, replaced w/ competitor revision stem, new depuy poly liner and competitor femoral head.Doi: (b)(6) 2017.Dor: (b)(6) 2019, left hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: null.Device history batch: null.Device history review:null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 6 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9167889
• Report Number: 1818910-2019-108405
• Device Sequence Number: 3884423
• Product Code: KWA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101214060
• Device Lot Number: HG1148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 10D 40IDX56OD.; DLT TS CER HD 12/14 40MM +8.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 112