MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74121150
Medical Device Problem Codes	Mechanical Problem (1384); Biocompatibility (2886); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561); Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery on (b)(6) 2023.No additional information was provided.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to an unspecified adverse event.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.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.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.
Additional Manufacturer Narrative
Additional information: a2, b5, b7, d1, d4, d6a, h6, g2.
Event or Problem Description
It was reported that, after undergoing right hip resurfacing (bhr) on (b)(6) 2008 due to osteoarthritis, the patient presented worsening hip pain and evidence of acetabular osteolysis in conjunction with hip prothesis mechanical complication.These events were treated by performing a revision surgery on (b)(6) 2023, in which the bhr femoral head was explanted, and the cup was retained.During this procedure, evidence of mild to moderate metal staining of the soft tissues was noted.Smith and nephew¿s dual mobility insert was placed, along with a competitor¿s femoral head and stem (djo inc).The patient was transferred to the post-anesthesia care unit in stable condition.
Additional Manufacturer Narrative
Section h3, h6: it was reported that hip revision surgery was performed due to hip pain, evidence of acetabular osteolysis, and hip prothesis mechanical complication.As of today, the devices, which were used in treatment, have not been returned for evaluation.As no batch numbers were provided a full complaint history review could not be performed for the devices.A review of the historical complaints data for the bhr head and cup was instead performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints have been identified for the part number and the reported failure mode in this timeframe, and this failure will continue to be monitored through routine monthly trending.The dhr task could not be performed as reasonable effort to obtain a lot/batch/serial number has not been successful.Should the lot/batch/serial number become available later then the dhr task will be reopened and completed.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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Although the reported pain and osteolysis along with the intraoperative findings of metal stained soft tissues may be consistent with a reaction to metal debris, the source and the clinical root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with a malperformance of the implant or implant failure.The impact to the patient beyond the revision surgery cannot be determined.Based on the information provided we cannot further investigate the complaint our investigation remains inconclusive and 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 and trauma to the joint replacement.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• 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: 16928307
• Report Number: 3005975929-2023-00065
• Device Sequence Number: 20563202
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2023

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 Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: UNKNOWN
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 06/28/2023; 08/04/2023
• Initial Report FDA Received Date: 05/14/2023
• Supplement Report FDA Received Date: 06/08/2023; 07/06/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74120156/ACETLR CUP HAP 56MM W/ IMPTR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male