MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL 13.5 STD 8.0 FULL PC 12/14; HIP FEMORAL STEM/SLEEVE

Catalog Number	157114000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/15/2017
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.
Event or Problem Description
Der states that the patient had what looked like an 8" depuy solution stem and a duraloc multi hole cup.Unknown hospital of surgery and date.Unknown product numbers except what could get off implants explanted.The 8" stem 13.5 mm broke in half.Surgeon removed proximal portion and trephined out the distal portion.Surgeon put new revision stem in and new liner into existing duraloc cup.No instrumentation broke during procedure.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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 13.5 STD 8.0 FULL PC 12/14
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6948215
• Report Number: 1818910-2017-26490
• Device Sequence Number: 795477
• Product Code: LPH
• UDI-Device Identifier: 10603295060758
• UDI-Public: 10603295060758
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 157114000
• Device Lot Number: UP3AW1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/13/2017
• 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
• Patient Weight: 80