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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)

Event Date 12/21/2018

Event Type  Injury  

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 Description

Medical records received.After review of medical records, the patient had undergone an irrigation and debridement on (b)(6) 2018 to address infection.Head and liner were revised and an unspecified resorbable antibiotic carrier was placed.No part/lot codes available for the implanted liner and head, but these were identified to be a depuy pinnacle polyethylene inlay neutral 52/32 mm and a biolox ceramic revision head, diameter 32 mm + 1 mm.The patient had postoperative anemia and so was transfused with 7 units packed red blood cells.On (b)(6) 2018, the patient had undergone an irrigation and debridement for post-operative redness of the right hip wound with evidence of infection.No implants were revised at this time.On (b)(6) 2019, the patient had undergone a third irrigation and debridement to address inflammation, infection, to evacuate a hematoma and to address rupture of fascia after change of the ruptured ceramic parts of a cementless tep.The tissue was infected, there was dehiscence of the fascia and necrosis.No products were revised.Doi: (b)(6) 2018; - dor: (b)(6) 2018; (right hip).Cup was previously reported under (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pathology report dec.21, 2018 indicates receipt of connective tissue specimens from intra-operative collection.Findings include scarred soft tissue with reactive bone and cartilage changes.Slight chronic synovitis, inflammation and florid purulent discharge.It is indicated that the patient was diagnosed between (b)(6) 2018 and from (b)(6) 2019, with chronic renal failure and nstemi.The patient has a complex medical history with multisystem involvement.There is no indication that depuy product caused or contributed to the patients diagnosis of chronic renal failure and / or nstemi.

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.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.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 4 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9375400
• MDR Text Key: 181631710
• Report Number: 1818910-2019-117989
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295001065
• UDI-Public: 10603295001065
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1012-14-040
• Device Catalogue Number: 101214040
• Device Lot Number: 566410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR