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

Catalog Number	74123152
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530); High metal ion levels (4847); Radiolucent Lines (4848)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the plaintiff underwent a bhr resurfacing surgery performed on (b)(6) 2007, the patient presented pain, lucencies in the femoral neck region, and elevated levels of metal ions.A revision surgery was performed on (b)(6) 2016 to change it to total hip arthroplasty, explant the cup and femoral head, and replace them with competitor implants.There were signs of black material (metallosis) with pseudotumor, significant osteolysis of the superior-lateral aspect of the neck with compromised bone in this region, a large grater trochanteric bursa and a significant hypertrophic synovium.No infection was noted.A synovectomy and bursectomy were performed, and the pseudotumor was excised.The current patient health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: as of today, the explanted devices, all of which were used in the procedure, have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and cup, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.The reported pain, elevated metal ions, and intraoperative findings of osteolysis, black material and pseudotumor are consistent with the reported metallosis.However, the clinical root cause of the metallosis cannot be definitively concluded.The patient impact is the revision and postoperative convalescence period.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Event or Problem Description
It was reported that, after undergoing left bhr surgery on (b)(6) 2007 due to severe osteoarthritis, the patient presented pain, luscencies in the femoral neck region, and elevated levels of metal ions.A revision surgery was performed on (b)(6) 2016 for conversion to competitors¿ total hip arthroplasty system (pinnacle-summit).There were signs of black material (metallosis) with pseudotumor, significant osteolysis of the superior-lateral aspect of the neck with compromised bone in this region, a large greater trochanteric bursa and a significant hypertrophic synovium.No infection was noted.A synovectomy and bursectomy were performed, and the pseudotumor was excised.Patient¿s current health status is unknown.

• Brand Name: BHR RESURFACING 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18857037
• Report Number: 3005975929-2024-00030
• Device Sequence Number: 3306410
• Product Code: NXT
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 09/28/2012
• Device Catalogue Number: 74123152
• Device Lot Number: 07JW14021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP HAP SIZE 52/58, LOT#:07HW13201.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male