MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-04-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Anemia (1706); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	10/04/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Litigation papers allege: patient was implanted with a depuy asr hip implant on her right hip on or about (b)(6) 2009.Patient experienced pain and suffering; disability; impairment; loss of function, use and range of motion; decreased and poor hip performance; gait disturbance; metallic and other particulate contamination of the blood and body; exacerbation of underlying hip joint disorders; internal scarring; and irritation and injury to the tendons, ligaments, muscles, blood vessels, cartilages, nerves, bones and soft tissues of the hip joint and surrounding areas.Patient has not yet scheduled an explantation of the asr hip implant.The patient was revised due to displaced right hip prosthesis, avulsed total hip replacement.Operative note reported hematoma around joint and implant found laterally, cup was loose, fractured bone on acetabulum and was broken off in several pieces and were removed.The remainder of the acetabulum appeared benign.The hip joint abductor had been damaged.Patient suffered anemia due to blood loss.Blood transfusion and frozen plasma was given to the patient.Doi: (b)(6) 2009 - dor: (b)(6) 2009 (right side).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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.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 5 STD 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: 9699268
• Report Number: 1818910-2020-04565
• Device Sequence Number: 19423660
• Product Code: LZO
• UDI-Device Identifier: 10603295000761
• UDI-Public: 10603295000761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2011

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 Model Number: 1012-04-050
• Device Catalogue Number: 101204050
• Device Lot Number: DY4ECC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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: 44 YR
• Patient Weight: 70