MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

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

Event Date 12/13/2016

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pseudotumor and metallosis.Acetabular cup remained implanted.

Manufacturer Narrative

After further clarification and revision of the medical records, it is confirmed that no adverse event occured on right knee for this patient.Adverse event was only for left knee and this is already captured on internal reference (b)(4).No medical intervention, malfunction or serious injury was reported for this case.According to this information, this is a non valid complaint, if further information is received, this complaint can be re-opened and re-assesed.

Manufacturer Narrative

Please notice that on previous follow-up (001), it was mentioned that the other adverse event already reported was for right knee.This is a typo mistake and it must be read as follows: the adverse event already reported was for right hip.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7562221
• MDR Text Key: 109886219
• Report Number: 3005975929-2018-00186
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121146
• Device Lot Number: 080471
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120152, LOT # 083892
• Patient Outcome(s): Hospitalization; Required Intervention