MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 05/23/2019

Event Type  Injury  

Event Description

Revision surgery was performed due to audible squeaking reported by the patient.Surgeon reportedly determined that the posterior capsule had been compromised and there wasn't proper synovial fluid to lubricate the implants.

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: [248258 summary.Pdf].

• Brand Name: BHR FEMORAL HEAD 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; auroa house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8645010
• MDR Text Key: 146206992
• Report Number: 3005975929-2019-00223
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 74123152
• Device Lot Number: 17AW20029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention