MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 1 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214010
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Patient was revised to address pain.Additional information received via ppf and medical records.In additional to what were previously alleged, ppf alleges pseudotumor, clunking sound, inflammation, dislocation and decreased range of motion.After review of medical records,patient was revised to address adverse reaction to metal debris.Operative notes indicated small spot of corrosion at the trunnion with no obvious trunnionosis.Stem added to the complaint for the alleged corrosion.Added medical history and patient's age.Doi: (b)(6) 2008; dor: (b)(6) 2017, 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 1 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: 8887628
• Report Number: 1818910-2019-100878
• Device Sequence Number: 2863920
• Product Code: KWA
• UDI-Device Identifier: 10603295001034
• UDI-Public: 10603295001034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101214010
• Device Lot Number: CX1HW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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: 61 YR
• Patient Weight: 70