MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214060

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

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 02/08/2018

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

Pinnacle litigation received.Litigation alleged injury, bodily impairment, lack of mobility, infection, and pain.Doi: (b)(6) 2010; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

(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

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.Udi: (b)(4).

Event Description

Ppf alleges, pseudotumor, metal wear, metallosis, and elevated metal ions.After review of medical records, patient was revised to address periprosthetic osteolysis and trunion corrosion.Added dob, revision hospital, revision surgeon, age, weight, expiration date of impacted products.Corrected dor.Doi: (b)(6) 2010.Dor: (b)(6) 2018.Right hip.

• Brand Name: TRI-LOCK BPS SZ 6 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: 8016701
• MDR Text Key: 125381186
• Report Number: 1818910-2018-73805
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 101214060
• Device Lot Number: D5NES1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 62