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

Catalog Number 254500713

Device Problems Material Discolored (1170); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

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

Mdr staff has indicated products have become worn and discoloured from use.

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.

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.

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.

• Brand Name: ATTUNE CR FEM TRIAL SZ 3 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7944808
• MDR Text Key: 123067275
• Report Number: 1818910-2018-71695
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295133858
• UDI-Public: 10603295133858
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 10/11/2018; 11/19/2018; 12/20/2018
• Supplement Dates FDA Received: 10/17/2018; 12/20/2018; 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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