MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 74122546

Device Problems Corroded (1131); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Reaction (2414)

Event Date 05/16/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to an adverse reaction to metal.Taper corrosion noted.Cup and stem retained.

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.

• Brand Name: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8635208
• MDR Text Key: 145897478
• Report Number: 3005975929-2019-00219
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122546
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120154, LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN; ACETABULAR CUP, # 74120154, LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR