MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP FEMORAL IMPACTOR

Catalog Number	226777000
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
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
(b)(6) - reported to (b)(4) rep by csd staff.Deep gouges found by csd staff on surface of lcs femoral impactor.Deep chips on femoral trial surface.Not linked to a specific patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this reported event was not returned for evaluation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: HP FEMORAL IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7125408
• Report Number: 1818910-2017-51937
• Device Sequence Number: 11118692
• Product Code: HWA
• UDI-Device Identifier: 10603295108948
• UDI-Public: 10603295108948
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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: 226777000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1