MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK TI 15.0 LAT OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101212150

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 05/07/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle litigation received.Litigation alleges injury, pain, discomfort, loss of mobility, loss of range of motion, disfigurement, emotional distress, difficulty ambulating, mental anguish, metallosis which cause a large amount of toxic cobalt and chromium metal ions to be released in hip capsule, tissues, blood stream, and organs.Doi: (b)(6) 2006; dor: (b)(6) 2014; right hip.

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.

Manufacturer Narrative

(b)(4).

Event Description

Update ad 11 sep 2018.Pc was re-opened due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear.Added revision hospital, surgeon, dob, product details and expiration date.

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.Udi: (b)(4).

Event Description

In addition to what were previously alleged, pfs has no new allegation.After review of medical records, patient was revised to address failed acetabular component, there was evidence of corrosion between cobalt-chromium head from the stem.The cup did not show any evidence of loosening.All debris then removed.

• Brand Name: TRI-LOCK TI 15.0 LAT OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7885283
• MDR Text Key: 120551107
• Report Number: 1818910-2018-69648
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K872878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101212150
• Device Lot Number: AA6CMA000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR