MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV DST F AUGTRL 12XSZ5-6; FEMORAL TRIALS

Catalog Number	254705003
Medical Device Problem Codes	Corroded (1131); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional 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 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.The instrumentation was shipped a total of 8 times and was thoroughly cleaned 3 times with alcohol by an orthokit operator.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 12XSZ5-6
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8279452
• Report Number: 1818910-2019-82394
• Device Sequence Number: 1692128
• Product Code: LXH
• UDI-Device Identifier: 10603295439530
• UDI-Public: 10603295439530
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• 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: 254705003
• Device Lot Number: NW207498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1