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

Catalog Number	101214060
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	11/11/2019
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 original implant date unknown.Metal ion levels were co 24 cr 3.3, patient was not very symptomatic.Patient had a little bit of groin pain.Dr said there was some weird looking tissue maybe a little bit of a pseudotumor.There was corrosion at the head neck taper junction.Cup was removed and a zimmer cup was implanted with a poly liner.Stem was well fixed and left in, a 36+5 ts ceramic head was put in the stem.This is all the information i have.Doi: unknown; doir: (b)(6) 2019; left hip.
Additional Manufacturer 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.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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9413229
• Report Number: 1818910-2019-120410
• Device Sequence Number: 17176197
• Product Code: KWA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/26/2019
• 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: 64 YR