MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 20F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550536
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348)
Date of Event	10/26/2012
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
Patient was revised to address infection.Update 11/23/2012- litigation papers received.In addition to infection, it is now alleged that the patient suffers from pain and discomfort, swelling in the leg, and difficulty sleeping.Update ad 11 may 2018: the receipt of ppf and medical records received.Ppf has no new allegation.After review of medical records, patient was revised to address gross infection and hypertrophic scar.Revision notes reported that there was a full blown outward flow of pus after excision of the fascia and removing the calcar component made fractures and cracks and quarter size bone loss in the direct lateral part of the femur.
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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8088697
• Report Number: 1818910-2018-75973
• Device Sequence Number: 11199364
• Product Code: LPH
• UDI-Device Identifier: 10603295175360
• UDI-Public: 10603295175360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 550536
• Device Lot Number: 2849594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 09/20/2019
• 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: 32 YR
• Patient Weight: 82