MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 STD OFFSET; HIP FEMORAL STEM/SLEEVE

Catalog Number 101204020

Device Problem Incorrect Measurement (1383)

Patient Problems Not Applicable (3189); No Information (3190)

Event Date 07/24/2017

Event Type  malfunction  

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

It was reported that the size 2 std trilock stem seemed to be the wrong size.

Manufacturer Narrative

Examination of the returned device did not identify any out of specification condition.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. .

Event Description

Complaint description: it was reported that the size 2 std trilock stem seemed to be the wrong size./ | investigation method: / | investigation summary:.

• Brand Name: TRI-LOCK BPS SZ 2 STD OFFSET
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6813305
• MDR Text Key: 83365922
• Report Number: 1818910-2017-23263
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00603295000730
• UDI-Public: 0603295000730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101204020
• Device Lot Number: H38036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2017
• 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 Age: 61 YR