MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-040
Medical Device Problem Codes	Degraded (1153); Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
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).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
Pinnacle mom litigation records received.Litigation alleges pain, discomfort, emotional distress, disfigurement and injuries.In addition to what were previously alleged, ppf alleges metal wear, metallosis and elevated metal ions, while pfs alleges numbness, stiffness, instability, weakness, limited rom, soft tissue destruction and anxiety.After review of medical records, the patient was revised due to failed right tha, with metallosis and soft tissue destruction.Operative notes reported that upon entering he intra-articular spaces, metallosis debris was expelled and there was evident of some metal staining of the soft tissue.There was some trunnion corrosion and debris, but the trunnion looked intact.The femur was 5-10 degrees anterversion.Tte liner has some old staining behind it, including some metallosis and corrosion.Added stem and cup to the complaint.Product and lot numbers were provided.Added surgeon, medical history, patient dob, age, height and weight.Doi: (b)(6) 2010: dor: (b)(6) 2018: right hip.

• Brand Name: TRI-LOCK BPS SZ 4 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: 9610980
• Report Number: 1818910-2020-02391
• Device Sequence Number: 19437166
• Product Code: KWA
• UDI-Device Identifier: 10603295001065
• UDI-Public: 10603295001065
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Model Number: 1012-14-040
• Device Catalogue Number: 101214040
• Device Lot Number: D6DCKB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 01/28/2020
• 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: 67 YR
• Patient Weight: 66