MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; HIP PROSTHESIS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/11/2012

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient developed hip arthrosis.The patient was treated with medication and an unspecified revision hip surgery was performed.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.No further investigation is warranted at this time.

• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa TN CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau, TN 5001 ; SZ 5001 ; 9013991624
• MDR Report Key: 5129325
• MDR Text Key: 27520761
• Report Number: 1020279-2015-00709
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 78