MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SOL 10.5 MMA 8.0 FULL PC 12/14; HIP FEMORAL STEM/SLEEVE

Catalog Number	157152000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
It was indicated that the surgeon reported a hip stem is broken.The product is implanted in the patient.
Additional Manufacturer Narrative
Examination of the returned device confirms the reported observation.Error in manufacture and material was not identified.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: SOL 10.5 MMA 8.0 FULL PC 12/14
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6729194
• Report Number: 1818910-2017-21392
• Device Sequence Number: 13763808
• Product Code: LPH
• UDI-Device Identifier: 10603295061052
• UDI-Public: 10603295061052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157152000
• Device Lot Number: 123350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention