MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 17X22; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563622
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Cellulitis (1768); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	12/24/2014
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
Clinical adverse event received for cellulitis event is serious and is considered moderate.Event not related to device.Event is related to procedure.Doi: (b)(6) 2014, doe: (b)(6) 2014, (right knee).On (b)(6) 2014, the patient underwent a right total hip arthroplasty due to osteoarthritis.The components listed on (b)(4) correctly reflect the operative notes.On (b)(6) 2014, the patient experienced a witnessed fall and left the facility against medical advice and returned to the facility on the same day due to a periprosthetic femur fracture.On (b)(6) 2015, the patient underwent a revision of a right total hip arthroplasty due to failed right total hip arthroplasty secondary to loosening and periprosthetic fracture.The loosening is indicated to be the femoral component.The surgeon noted the proximal calcar fracture area was repaired with several 16-gauge stainless steel wires.
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.

• Brand Name: SROM STM STD 36+12L 17X22
• 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: 7356799
• Report Number: 1818910-2018-55647
• Device Sequence Number: 16492006
• Product Code: JDI
• UDI-Device Identifier: 10603295178248
• UDI-Public: 10603295178248
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 563622
• Device Lot Number: 3353144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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
• Patient Weight: 104