MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 0 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-14-005

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/14/2022

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

Patients was revised due to loosening. Stem subsided and became loose, so surgeon removed stem and head and replaced with an actis and a new femoral head. Doi: (b)(6) 2018, dor: (b)(6) 2022, affected side: right hip.

• Brand Name: TRI-LOCK BPS SZ 0 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: amy hendrickson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743674841
• MDR Report Key: 13949771
• MDR Text Key: 288191430
• Report Number: 1818910-2022-05764
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012-14-005
• Device Catalogue Number: 101214005
• Device Lot Number: 236562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/30/2022 Patient Sequence Number: 1

Treatment

ARTICULEZE M HEAD 36MM -2); TRI-LOCK BPS SZ 0 HI OFFSET