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

Catalog Number	74121150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); High metal ion levels (4847)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plaintiff underwent a right birmingham hip resurfacing via posterior approach on (b)(6) 2018.The patient suffered localized pain to the groin and creaking type of noise with certain movements.In addition, the patient presented elevated cobalt and chromium levels and a mri demonstrated some trace fluid around the bursa and abductor muscles.The patient also presented many systemic symptoms over the past year.This adverse event was treated by a revision surgery on (b)(6) 2023.During surgery, it was noticed there was some subtle metal staining in the adjacent hip capsule but no damage to the abductors, surrounding tissues, or bones.Hip resurfacing implants were removed and replaced.Patient also has a contralateral birmingham hip resurfacing.Patient was transferred to the recovery room in good condition.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(6).
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed due to pain, creaking noises, elevated cobalt and chromium levels, and a mri which demonstrated fluid around the bursa and abductor muscles.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 device history record could not be reviewed with a lot/batch/serial number.Should this detail become available, 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.No prior applicable escalation actions were identified.The available medical documents were reviewed.Based on the limited information provided, the clinical root cause of the reported pain, creaking, systemic symptoms, elevated cobalt level, serous fluid collection and metal staining cannot be confirmed.It cannot be concluded that the reported clinical symptoms were related to a malperformance of the implant.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.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.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.

• 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: 17683945
• Report Number: 3005975929-2023-00127
• Device Sequence Number: 6180095
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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: ACETLR CUP HAP 56MM W/ IMPTR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male