MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/16/2019

Event Type  Injury  

Event Description

Revision surgery was performed due to implantation of mismatched components.A 58mm cup was implanted with a 50mm resurfacing head instead of a 52mm head, as per correct labelling requirements.Hospital claims that labelling is insufficiently clear.Error was noticed after completion of implantation.Patient was returned to theatre on the same day to be revised.

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: BHR ACETABULAR CUP 58MM
• 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: 8598524
• MDR Text Key: 144659616
• Report Number: 3005975929-2019-00199
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2023
• Device Catalogue Number: 74122158
• Device Lot Number: 14JW00002A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2019
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121150, LOT # 18GW11263; FEMORAL HEAD, # 74121150, LOT # 18GW11263
• Patient Outcome(s): Hospitalization; Required Intervention