MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123144
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
*us legal mdl* it was reported that, after a bhr construct had been implanted on (b)(6) 2009, the plaintiff experienced pain, limited mobility, extensive metallosis and adverse local tissue reaction.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.During surgery, the cup was found to be in good position and well fixed, so the surgeon decided not to explant it.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that 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.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The bhr cup met manufacturing specifications at the time of production.No concessions were identified that could have contributed to this issue.A non-conformance was identified for the castings inspection procedure paperwork for the bhr head.However, all supporting documents confirm that this was an acceptable product when released.Review of the product instructions for use found adequate warnings and precautions in relation to the alleged failure modes.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 clinical information provided, of the pain, limited mobility, and adverse local tissue reaction in the hip may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 44MM
• 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: 11891193
• Report Number: 3005975929-2021-00282
• Device Sequence Number: 1389884
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 3596010552419
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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 Expiration Date: 05/30/2013
• Device Catalogue Number: 74123144
• Device Lot Number: 08EW17074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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; Required Intervention