MAUDE Adverse Event Report: DEPUY DEPUY SUMMIT SIZE SIX HIGH OFFSET TAPERED; HIP IMPLANT

Device Problem Contamination (1120)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)

Event Date 06/08/2007

Event Type  No Answer Provided  

Event Description

After hip surgery approximately ten days, hip got infected.However, had to have another surgery the second time.Hip never recover successfully.The device had to be replaced twice due to complications on hip.Hip got infected, and never ever recovered.Please call me in reference to this matter.Fluids: two thousand cubic centimeters of lactated ringer's.Urine output: not recorded.Disposition: the pt was extubated and transferred to the recovery room in stable condition.Indications: the pt is an (b)(6) year old male, who presented to (b)(6) hospital emergency room with complaint of right hip pain.X-rays were done which confirmed presence of a right femoral neck fracture.The pt was admitted to the orthopedic service with the plan of undergoing right hip hemiarthroplasty once cleared by the medicine service.The risks and benefits of the procedure were explained to the pt, who understood the risks and wished to proceed with surgery.Procedure: the pt was identified in the preoperative holding area where the right hip was marked as the operative site.The pt was then taken to the operating room per anesthesia.Once in the operating room, the pt was sedated and intubated per anesthesia.The pt was then placed in the left lateral decubitus position.The right hip and lower extremity were then scrubbed with soap and water and then rubbed down with alcohol.The right lower extremity was then prepped and draped in usual sterile fashion.A standard curvilinear incision was made over the right greater trochanter.The incision was taken down through skin and subcutaneous tissue down to the level of the tensor.

• Brand Name: DEPUY SUMMIT SIZE SIX HIGH OFFSET TAPERED
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY
• MDR Report Key: 3653200
• MDR Text Key: 4316320
• Report Number: MW5034752
• 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: Other
• Type of Report: Initial
• Report Date: 06/04/2007
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR