MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number 74121154

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Test Result (2695)

Event Date 11/19/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Subsequent revision surgery involving unspecified devices (b)(6) 2017.Metallosis and fluid collection reported.

Manufacturer Narrative

Part details in section amended to better reflect clarified event description subsequently received.(b)(4).

Event Description

Acetabular cup remained implanted.Subsequent revision captured via mdr 3005975929-2018-00098.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.- attachment: [162343 summary.Pdf].

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6899971
• MDR Text Key: 87588740
• Report Number: 3005975929-2017-00335
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Catalogue Number: 74121154
• Device Lot Number: 57921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120162, LOT # 54625R; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR