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

Model Number	74123152
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr construct had been implanted on (b)(6) 2010, the patient experienced metallosis or elevated metal ions.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The femoral head 52mm was explanted during this surgery and it was replaced with a bhr dual mobility insert from smith and nephew.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.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.Without definitive part and lot numbers a complete complaint history review cannot be performed for the bhr cup involved.Without definitive lot numbers a complete complaint history review cannot be performed for the bhr head involved.A review of the complaint history for the bhr head was performed using part numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the bhr head.This will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The implantation operative report and provided x-ray did not aid in the clinical investigation of the reported elevated metal ions and metallosis.Without adequate materials to fully evaluate the complaint, a thorough medical assessment cannot be performed.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.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: FEMORAL HEAD 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11907579
• Report Number: 3005975929-2021-00289
• Device Sequence Number: 19114592
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74123152
• Device Catalogue Number: 74123152
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention