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

Model Number	74120150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem Description
It was reported that the patient underwent revision surgery on the right hip, after a primary bhr resurfacing system surgery, due to pain, limited mobility and elevated metal ion levels.Only the head was explanted, a new liner, head and stem was implanted.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, the femoral head was removed.The 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 cup, femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the head and cup.However, as bhr systems of this size are no longer sold, no action is to be taken.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.Review of the product ifu 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.It should be noted the surgical technique contraindications include ¿patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.Although ¿cobalt and chrome labs demonstrate evidence of metallosis and articular surface bearing wear¿ was reported the intraoperative report did not note findings of metallosis and without the return of the device no thorough evaluation of the reported ¿articular surface bearing wear¿ can be performed.Based on the information provided, it cannot be concluded that the reported findings are related to the s+n product.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined 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: RESURFACING FEMORAL HEAD 42MM
• 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: 11183207
• Report Number: 3005975929-2021-00013
• Device Sequence Number: 14401612
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 74120150
• Device Catalogue Number: 74121142
• Device Lot Number: 082836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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