MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problem Biocompatibility (2886)

Patient Problems Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported that, after a right primary bhr-tha surgery, performed (b)(6) 2009, the plaintiff had a revision surgery on (b)(6) 2021.During which a clear grayish fluid, indicative of metal on metal wear was found; the acetabulum was also loose.The bhr acetabular cup, modular sleeve, and hemi head were replaced for aesculap components.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

It was reported that, after a right primary bhr-total hip arthroplasty surgery, the patient had a revision surgery.During which a clear grayish fluid, indicative of metal on metal wear was found; the acetabulum was also loose.The bhr acetabular cup, modular sleeve, and hemi head were replaced for competitor's components.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for device cup and head, and no other similar complaints have been identified for the sleeve.This failure will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product 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 available medical documents were reviewed.The ifu (81040829 rev.0 12/05) for the birmingham hip¿ resurfacing (bhr¿) system warnings and precautions notes, ¿do not use any component of the bhr system with another manufacturer¿s implant components, because designs and tolerances may be incompatible.¿ the mixed manufacturer components cannot be ruled out as a possible contributing factor to the reported clinical reactions.The reported ¿clear grayish fluid, indicative of metal-on-metal wear and acetabular defect, which can be seen as a result of metallosis, but the loosening could also accelerate wear and lead to metal debris and result in metallosis.With the information provided, the clinical root cause of the reported metal-on-metal wear cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision cannot be determined with the provided information.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, loosening of components may increase production of wear particles and accelerate damage to the bone.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: ACETLR CUP HAP 52MM W/ IMPTR
• 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: 17936209
• MDR Text Key: 325674942
• Report Number: 3005975929-2023-00149
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 3596010502575
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 093662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2746-2015
• Patient Sequence Number: 1
• Treatment: 74122546 / LOT# 08JW18830.; 74222100 / LOT # 08GW17830.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female