MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 3 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101204030

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

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

The size 3 trilock stems were not sitting at an acceptable depth relative to the size 3 trilock broach.After rebroaching the canal the stem still sat at a cm above the desired depth.We opened yet another stem and had the same issue.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Related dimensional inspection of the returned product found no discrepancy from drawing requirements.No product problem 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.Device history lot =null.Device history batch =null.Device history review =null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 3 STD OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8186940
• MDR Text Key: 131084832
• Report Number: 1818910-2018-78923
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000747
• UDI-Public: 10603295000747
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101204030
• Device Lot Number: HY7468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 01/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention