MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM LG,36NK,16X11X205N; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	526516N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2011
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
Ppf and sticker sheets received.Ppf alleges fracture (component).It was indicated in the ppf and sticker sheets that cup, liner, screw, head , sleeve and stem were revised on(b)(6) 2011.Doi: (liner, cup, screw): (b)(6) 2008.Doi: (head, stem, sleeve): (b)(6) 2009.Dor: (b)(6) 2011, (right hip).Insufficient information has been provided to determine which implant has fractured.At this time, the srom stem has been reported to capture the fracture event.If / when additional information is provided, a follow-up medwatch submission will be sent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8771277
• Report Number: 1818910-2019-97814
• Device Sequence Number: 16571150
• Product Code: JDI
• UDI-Device Identifier: 10603295171249
• UDI-Public: 10603295171249
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Expiration Date: 02/28/2011
• Device Catalogue Number: 526516N
• Device Lot Number: 2092693
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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 Age: 48 YR