MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 ATTUNE CONV SHIM SZ7 18MM; KNEE INSTRUMENT/TRIAL

Catalog Number	254500944
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the attunem shim sz5 14mm and attunem shim sz7 16mm have cracked around the metal insert area.It was also reported that the attunem shim sz7 18mm has started to come out of the shim body.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Examination of the returned devices confirms the reported event.Depuy considers the investigation closed at this time.Should the 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 CONV SHIM SZ7 18MM
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6710315
• Report Number: 1818910-2017-21069
• Device Sequence Number: 992110
• Product Code: HWT
• UDI-Device Identifier: 10603295135210
• UDI-Public: 10603295135210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2017

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: 254500944
• Device Lot Number: BFA0W7X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 07/31/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 07/21/2017; 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1