MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 S-ROM*18X12X160 STEM,36MM NECK; FEMORAL STEM

Catalog Number	875973
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Seventeen years ago, tha surgery was performed at another hospital using the s-rom modular hip system.Three years ago, it was confirmed through an x-ray that the stem was broken at its distal end.On (b)(6) 2017, revision surgery was performed due to a femoral transverse fracture caused by the patient¿s fall, which was confirmed near 3 cm from the distal end.During the surgery, the stem and sleeve as well as the broken parts were removed.No further information regarding the surgery has been provided from the hospital.
Additional Manufacturer Narrative
Pc(b)(4).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device did not identify a product problem.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. .

• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork DE ; EI
• MDR Report Key: 7060275
• Report Number: 1818910-2017-50234
• Device Sequence Number: 11271778
• Product Code: JDI
• UDI-Device Identifier: 10603295218920
• UDI-Public: 10603295218920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2017

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: 875973
• Device Lot Number: 807414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 12/14/2017; 03/09/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 11/29/2017; 12/27/2017; 03/13/2018
• 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