MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FEM TRIAL SZ 3 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number	254500713
Medical Device Problem Codes	Material Discolored (1170); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Mdr staff has indicated products have become worn and discoloured from use.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned.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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM TRIAL SZ 3 LT
• Common Device Name: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7948633
• Report Number: 1818910-2018-71841
• Device Sequence Number: 11326605
• Product Code: JWH
• UDI-Device Identifier: 10603295133858
• UDI-Public: 10603295133858
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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: 254500713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 11/19/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/17/2018; 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1