MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-040

Device Problem Migration (4003)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  malfunction  

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.

Event Description

It was reported that in (b)(6) 2018, the patient fell from a truck bed and fractured his femoral neck and underwent the bha surgery with the stem.The date of fall and the surgery is unknown.After the surgery, the patient complained of pain during hospitalization, but was discharged from the hospital.After that, although the patient was followed regularly, but the occurrence of migration of the stem had not been noticed, and the surgeon found the migration of the stem at the latest medical examination.X-ray showed that migration had been considerably progressing from 1 year ago.The surgeon said that migration might have progressed quickly because the patient was still very active, such as loading and unloading trucks, and he is still in his 50s.In addition, the bone on the greater trochanter side of the stem has dissolved, and infection is suspected.The revision surgery via tha is scheduled on (b)(6) 2021.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: TRI-LOCK BPS SZ 4 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: 12495501
• MDR Text Key: 272172524
• Report Number: 1818910-2021-20468
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000754
• UDI-Public: 10603295000754
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-04-040
• Device Catalogue Number: 101204040
• Device Lot Number: HP3648
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +5 BR; J-FX BIPOL SHELL&28MMLINR/51MM; TRI-LOCK BPS SZ 4 STD OFFSET