MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK TI 13.8 LAT OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101212138

Device Problems Corroded (1131); Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Discomfort (2330); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

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

(b)(6) 2017: asr litigation record received.Litigation alleges damages, injuries, pain, stiffness, discomfort and weakness that affects mobility.Plaintiff suffers from toxicity of the metal in the body and was injured by excessive levels of chromium and cobalt.(b)(6) 2008; (b)(6) 2017; right hip (asr).

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot: z32br1000.Device history batch: null.Device history review: no deviations or anomalies were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H6 patient code: no code available (3191) was used to capture surgical intervention.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.

Event Description

After review of medical records patient was revised to addressed failed right total hip arhtroplasty with pseudotumor.Some corrosion noted on the femoral trunnion, minimal bone loss and a cystic contained acetabular defect noted.Added laboratory result, age, height and weight of patient.Doi: (b)(6) 2008 dor: (b)(6) 2017 right hip.

Manufacturer Narrative

Product complaint # (b)(4).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 caused or contributed to the potential event described in this report.

• Brand Name: TRI-LOCK TI 13.8 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: 7211799
• MDR Text Key: 97959350
• Report Number: 1818910-2018-51739
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/29/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 101212138
• Device Lot Number: Z32BR1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 06/06/2018; 04/03/2019; 08/01/2019; 04/27/2020; 05/20/2020
• Supplement Dates FDA Received: 02/02/2018; 06/08/2018; 04/09/2019; 08/19/2019; 05/17/2020; 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 90