MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUN REV DST F AUGTRL 8XSZ3-4; FEMORAL TRIALS

Catalog Number	254703002
Medical Device Problem Codes	Corroded (1131); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem 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: ATTUN REV DST F AUGTRL 8XSZ3-4
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8280875
• Report Number: 1818910-2019-82410
• Device Sequence Number: 1952867
• Product Code: LXH
• UDI-Device Identifier: 10603295439523
• UDI-Public: 10603295439523
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254703002
• Device Lot Number: NW199028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1