MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT/TRIAL

Catalog Number	950501219
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/20/2017
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 while impacting the femoral component onto the distal femur, small pieces broke off and fell around the implant and into the surrounding tissue.
Additional Manufacturer Narrative
Examination of provided photographs 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.
Additional Manufacturer Narrative
The device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.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.
Additional Manufacturer Narrative
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: LCS HP FEM NOTCH IMPACTOR
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6804245
• Report Number: 1818910-2017-23090
• Device Sequence Number: 1204636
• Product Code: HWA
• UDI-Device Identifier: 10603295225263
• UDI-Public: 10603295225263
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2017

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: 950501219
• Device Lot Number: PG1208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 09/05/2017; 09/15/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/12/2017; 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR