MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 0 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204005
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event	11/21/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: attorney.
Event or Problem Description
Complaint description: jun 27, 2017: litigation received.Litigation alleges erosion of the acetabulum, femur and surrounding structures, resulting in severe pain and a limp, dislocation, metallosis, and fluid buildup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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 = > cn8dl1000.Device history batch = > null device history review = > two anomalies were found in the addendum.The batch was on (b)(4) which was for possible undersized neck width conditions.The disposition of product on this ncr was accepted.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 0 STD 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: 8263878
• Report Number: 1818910-2019-81544
• Device Sequence Number: 2321727
• Product Code: KWA
• UDI-Device Identifier: 10603295000716
• UDI-Public: 10603295000716
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 101204005
• Device Lot Number: CN8DL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 68