MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121154

Device Problem Biocompatibility (2886)

Patient Problem Unequal Limb Length (4534)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Internal refrence number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, after undergoing right hip resurfacing (bhr) surgery due to osteoarthritis on (b)(6) 2008, the patient experienced metal-on-metal articulation with elevated serum metal ion levels.This event was addressed by performing a revision surgery on (b)(6) 2022, in which the femoral component was explanted, and a competitor¿s tha dual mobility construct (stryker) was placed for the indwelling socket.During this procedure, a discrepancy between the leg lengths was observed.Intraoperatively, both resurfacing components were confirmed to be well-fixed, and upon femoral head removal, the metal components were normal in appearance without evidence of wear or damage.There was no macroscopic evidence of metal debris, and the surrounding soft tissue envelope was healthy in appearance.Surgery was successfully completed, and the patient was transferred to the post-anesthesia care unit in stable condition.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed due to metal-on-metal articulation with elevated serum metal ion levels.As of today, the devices, which were used in treatment have not been returned for evaluation.A review of the historical complaints data for devices reportedly involved in this incident.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.As no batch numbers were provided a review of similar failure modes related to the batch could not be performed for the cup or head.Other similar complaints have been identified for the part number and the reported failure mode for the cup and head in this timeframe, and this failure will continue to be monitored through routine monthly complaint trending.Without a provided batch number, the manufacturing records for the devices cannot be reviewed.Should more information be provided at a later date, this 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 was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.With the limited information provided the clinical root cause of the reported elevated metal ions and small effusion cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period 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, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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 54MM
• Type of Device: 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: 17092071
• MDR Text Key: 316857162
• Report Number: 3005975929-2023-00095
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 74120160/ACETLR CUP HAP 60MM W/ IMPTR.
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male