MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK TI 10.0 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101211100

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

Patient Problems Necrosis (1971); Pain (1994); Tissue Damage (2104); Anxiety (2328); Injury (2348); Joint Dislocation (2374); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Pinnacle mom litigation records received.Litigation alleges pain, injuries, elevated metal ion levels, lack of mobility, anxiety, emotional distress, and loss of quality of life.It was stated that during the revision surgery, surgeon found a pseudotumor with necrotic type material, metal head to have gross metallosis along femoral neck portion outside of the trunnion, osteolysis, and a tan type material at the interface between the liner and shell.It was also alleged that plaintiff had two dislocations and a second hip revision surgery.Doi: (b)(6) 2006; dor:(b)(6) 2017; right hip.

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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.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 TI 10.0 STD OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8390723
• MDR Text Key: 137836475
• Report Number: 1818910-2019-86450
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101211100
• Device Lot Number: ZK2EX1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR