MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-030

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/31/2020

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

It was reported that the patient had a right tha performed on (b)(6) 2020.The patient was doing great until she tripped on carpet at home.From the xrays she fx her femur and has a periprosthetic fracture.The surgeon wanted to remove the trilock stem and head, and put in a corail revision stem while cabling the femur.The surgeon liked the final result in regards to leg length, offset, and new stability with the corail revision stem.Doi: (b)(6) 2020, dor: (b)(6) 2020, right side.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A review of a singular x-ray image does find sufficient evidence to confirm the reported bone fracture.No device error is not however identified.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.

• Brand Name: TRI-LOCK BPS SZ 3 STD 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: 10403419
• MDR Text Key: 202778748
• Report Number: 1818910-2020-18092
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000747
• UDI-Public: 10603295000747
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-04-030
• Device Catalogue Number: 101204030
• Device Lot Number: J62X47
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 32 MM +5; DELTA CER HEAD 12/14 32 MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR