MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV DST F AUGTRL 12XSZ3-4; FEMORAL TRIALS

Catalog Number 254703003

Device Problems Corroded (1131); Problem with Sterilization (1596)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).Investigation summary: evaluation of the returned device was unable to identify foreign material present; however, discoloration was noted.Depuy considers the investigation closed at this time.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

In depuy loaner department metal debris was seen on femur augments of the attune revision sets.All augments were affected but different degrees.The instrumentation was ready packed for shipment.In addition, there are noticeable rust marks, probably from the engraving.This was seen internally; no patient involvement, no surgery delay.

• Brand Name: ATUN REV DST F AUGTRL 12XSZ3-4
• Type of Device: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8280880
• MDR Text Key: 134182939
• Report Number: 1818910-2019-82411
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295439509
• UDI-Public: 10603295439509
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254703003
• Device Lot Number: NW199427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1