MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING HEAD 42; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/08/2008

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to luxation of the femoral head.Acetabular cup retained.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to luxation of the femoral head.During the revision, the bhr head was removed, the bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.No medical documents were received for investigation.Therefore no medical assessment can be performed.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR RESURFACING HEAD 42
• 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: 8319472
• MDR Text Key: 135492184
• Report Number: 3005975929-2019-00062
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 03596010502773
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2008
• Device Catalogue Number: 74121142
• Device Lot Number: 27522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120150, LOT # 27636; ACETABULAR CUP, # 74120150, LOT # 27636
• Patient Outcome(s): Hospitalization; Required Intervention