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

Model Number	1012-14-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Test Result (2695); No Code Available (3191)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 claim submission form alleges elevated metal ions and infection.After review of medical records patient was revised to address infected right total hip replacement.Revision notes reported a septic with infected right hip and positive blood cultures.There was more purulent material.The remainder of the hip did show a lot of hematoma.4 units of blood given for the intraop blood loss as well as the preop anemia.Surgical pathology reported of acute inflammation, doi: (b)(6) 2008; dor: (b)(6) 2019 (right hip).2nd stage revision was performed on (b)(6) 2019 for the removal of cement spacer, conversion to total hip replacement.
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.

• Brand Name: TRI-LOCK BPS SZ 5 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: 10241969
• Report Number: 1818910-2020-15229
• Device Sequence Number: 2496371
• Product Code: KWA
• UDI-Device Identifier: 10603295001072
• UDI-Public: 10603295001072
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 1012-14-050
• Device Catalogue Number: 101214050
• Device Lot Number: C4BBV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 40MM M SPEC+5; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 5 HI OFFSET; 12/14 ARTICUL 40MM M SPEC+5; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 5 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR