MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ3 HI; HIP FEMORAL STEM/SLEEVE

Catalog Number	157013090
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/03/2017
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
Der states that the nurse was removing implant femoral stem, there were 3 plastic pins on implant from blue wrapper, pulled implant from wrapper 2 pins detached themselves from implant.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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: SUMMIT CEMENTED STEM SZ3 HI
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582 0988
• MDR Report Key: 7053994
• Report Number: 1818910-2017-29622
• Device Sequence Number: 19105280
• Product Code: JDI
• UDI-Device Identifier: 10603295060222
• UDI-Public: 10603295060222
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013352
• 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): 10/25/2017

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: 157013090
• Device Lot Number: D16070672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1