MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 8 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204080
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	04/19/2013
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
Litigation alleges that the patient suffers from pain.Update (b)(6) 2013 - it has been reported that the patient's right hip was revised on (b)(6) 2013 to address a malpositioned acetabular component thought to have led to increased metal ion level.Patient also had pain.Updated may 29, 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf, medical records and sticker sheets.In addition to what were previously alleged, pff alleges metal wear and metallosis.After review of medical records, medical records provided implant record.Doi: (b)(6) 2009 - dor: (b)(6) 2013: (right hip).
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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: TRI-LOCK BPS SZ 8 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7702641
• Report Number: 1818910-2018-64794
• Device Sequence Number: 732843
• Product Code: KWA
• UDI-Device Identifier: 10603295000792
• UDI-Public: 10603295000792
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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 Expiration Date: 03/01/2019
• Device Catalogue Number: 101204080
• Device Lot Number: DH8CA1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 12/07/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/25/2018; 12/13/2018
• 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: 46 YR