MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT STEP WEDGE SZ3 10MM; KNEE TIBIAL TRAY

Catalog Number	129456131
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2017
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 during the case, the surgeon opened the mbt revision 10mm size 3 augment from the sterile internal packaging and the implant had a white looking powder on the surface, took a picture of the white powder on the implant and then it was rinsed with sterile saline.Since we implanted 2 each, size 3 10mm augments we weren't sure which lot number had the white powder.Both lot numbers are included below.
Additional Manufacturer Narrative
The device associated with this report was not returned.Examination of a submitted photograph confirmed the reported event.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: MBT STEP WEDGE SZ3 10MM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6911724
• Report Number: 1818910-2017-25827
• Device Sequence Number: 13483888
• Product Code: NJL
• UDI-Device Identifier: 10603295026723
• UDI-Public: 10603295026723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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: 129456131
• Device Lot Number: 316704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 109