MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)

Catalog Number UNKN01102109

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Date 05/14/2019

Event Type  Injury  

Event Description

On the literature article named "conversion of hip resurfacing with retention of monoblock acetabular shell using dual-mobility components", it was reported that, from the bc group, 20 patients underwent revision surgeries due to complications related to elevated ion levels and alval.The femoral head and the cup were explanted.The outcome of the patients is unknown.

Manufacturer Narrative

H3, h6: on the literature article named "conversion of hip resurfacing with retention of monoblock acetabular shell using dual-mobility components", it was reported that, from the bc group, 20 patients underwent revision surgeries due to complications related to elevated ion levels and alval.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review & risk management review could not be performed.All of the devices would have met manufacturing specifications.If more information is received, this investigation will be reopened.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.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: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)
• Type of Device: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11843304
• MDR Text Key: 251291279
• Report Number: 3005975929-2021-00269
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention