MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 7 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214070

Device Problems Material Discolored (1170); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 11/14/2016

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.

Event Description

Pinnacle litigation received.Litigation alleges severe pain, which affects his ability to walk and sit.Radiograph showed osteolysis and showed a large fluid collection with debris consistent with a granulomatous pseudotumor secondary to metal reaction.It was also reported that there was mild amount of fluid and some brownish staining of the synovial tissues throughout, but no significant pseudotumor.Doi: (b)(6) 2008: dor: (b)(6) 2016; (right hip).This complaint is linked to (b)(4); (left hip).Update 4 jun 2018 pinnacle ppf received.In addition to what were previous alleged, ppf alleges elevated metal ions.However, it was previously confirmed that the blood levels for metal ions were below 7(no unit provided).Shall there be new information.

Manufacturer Narrative

Pc(b)(4).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.

• Brand Name: TRI-LOCK BPS SZ 7 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7660155
• MDR Text Key: 113074100
• Report Number: 1818910-2018-63730
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295001096
• UDI-Public: 10603295001096
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101214070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Date Device Manufactured: 05/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 154