MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS S-ROM STYLE FEMORAL SLEEVE

Lot Number CD2BY4000

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/06/2016

Event Type  Injury  

Event Description

While waiting to board a bus in (b)(6), i got up to walk and a screw attaching my femoral stem to the knee joint broke.The left knee prosthesis was put in on (b)(6) 2009.Indications for procedure: mr.(b)(6) is a(b)(6) gentleman who first had a femur fracture, which healed with 100 percent displacement and shortening.The patient subsequently underwent total knee arthroplasty, which was unstable and then again revision to a hanger prosthesis.There may have been more than one stopping involved, as there was at least a liner exchange at one point.The patient presents at this time with a painful and radiographically loosening.

• Brand Name: S-ROM STYLE FEMORAL SLEEVE
• Type of Device: S-ROM STYLE FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS
• MDR Report Key: 6212410
• MDR Text Key: 63626584
• Report Number: MW5066964
• Device Sequence Number: 1
• Product Code: LWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/08/2016

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
• Device Operator: No Information
• Device Lot Number: CD2BY4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 129