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 Code	High metal ion levels (4847)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the plaintiff underwent a right bhr primary procedure on (b)(6) 2013.After this, patient developed asymptomatic elevated cobalt and chromium ion levels.This was treated by performing a revision surgery of the bhr implants on (b)(6) 2019.During the revision surgery, the bhr cup was deemed to be satisfactory and therefore, was retained; and no abnormal staining of the tissues could be identified.The bhr femoral head was explanted and replaced with an oxinium head and synergy stem.The patient also had a left metal on metal competitor implant which was revised the same day.No further complications were reported.Patient¿s current health status is unknown.
Additional Manufacturer Narrative
D10 concomitant medical products and therapy dates.It was reported that right hip revision surgery was performed due to asymptomatic elevated cobalt and chromium ion levels.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.No prior applicable escalation actions were identified.The available medical documents were reviewed.The bhr surgical technique indicates ¿sequential reaming with hemispherical acetabular reamers is then performed and in normal consistency bone, reaming proceeds to 2mm less than the definitive acetabular component to be inserted.¿ it cannot be determined to what extent the over-reaming of the right acetabulum had on the patient¿s reported elevated cobalt and chromium ion levels.The contralateral hip with depuy implants cannot be ruled out as a contributing factor to the reported ion levels.The patient impact beyond the reported events cannot be determined with the limited information provided.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.E1 initial reporter name and address.

• 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: 17675071
• Report Number: 3005975929-2023-00120
• Device Sequence Number: 7278711
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• 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: 2013
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/03/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETLR CUP HAP 56MM W/ IMPTR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male