MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that on literature review "birmingham hip resurfacing for osteoarthritis, a canadian retrospective cohort study with a minimum 10-year follow-up", after a bhr resurfacing surgery performed due to osteoarthritis, patient experienced an aseptic femoral loosening.This adverse event was treated with a revision surgery 102 months after implantation.A conversion from bhr resurfacing to a bhr tha was performed.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

Internal reference number: case (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Bourget-murray j, watt kearns sj, piroozfar s, lukenchuk j, johnston k, werle j.Birmingham hip resurfacing for osteoarthritis - a canadian retrospective cohort study with a minimum 10-year follow-up.Can j surg.2022 may 3;65(3):e296-e302.Doi: 10.1503/cjs.013320.

Manufacturer Narrative

H7 / h9: the concomitant device (74120148) also has a recall: z-2746-2015.H3, h6.It was reported that on literature review "birmingham hip resurfacing for osteoarthritis ¿ a canadian retrospective cohort study with a minimum 10-year follow-up", after a bhr resurfacing surgery performed due to osteoarthritis, patient experienced an aseptic femoral loosening.This adverse event was treated with a revision surgery 102 months after implantation.As of today, the implanted devices, all of which were used in treatment are not accessible for testing.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The clinically relevant patient-specific supporting documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient¿s outcome beyond that which was documented in the article could not be confirmed nor concluded; 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 42MM
• 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: 16820471
• MDR Text Key: 314074354
• Report Number: 3005975929-2023-00055
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: 74120148/ACETLR CUP HAP 48MM W/ IMPTR
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female