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

Catalog Number 101204020

Device Problem Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/12/2017

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

Der states that the size 2 stem was much thicker than the profile of the broach.The surgeon requested another stem because he could tell just by looking at it that it was too large.It sat over a cm proud of the broach.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned product finds nothing outward to suggest a product problem.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: der states that the size 2 stem was much thicker than the profile of the broach.The surgeon requested another stem because he could tell just by looking at it that it was too large.It sat over a cm proud of the broach.

• 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. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6942080
• MDR Text Key: 89692442
• Report Number: 1818910-2017-26383
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000730
• UDI-Public: 10603295000730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• 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,Followup
• Report Date: 09/12/2017

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: C60577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 03/06/2018
• Supplement Dates FDA Received: 10/24/2017; 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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: 65 YR
• Patient Weight: 100