MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 62MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120162

Device Problem Biocompatibility (2886)

Patient Problems Fatigue (1849); Discomfort (2330); Unspecified Eye / Vision Problem (4471)

Event Date 02/20/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was reported that, on (b)(6) 2008 a right bhr-thr was carried out due to osteonecrosis of the hip.Later, the plaintiff started developing pain in the groin and buttock regions, around 2012.Furthermore, they also developed nonspecific fatigue, issues with vision and general malaise, possibly attributed to elevated metal ions, therefore a revision surgery was performed, on (b)(6) 2014.During the revision it was found that the implants were well placed; the acetabular shell and modular head were exchanged for an r3 shell and oxinium head.The patient was discharged in stable condition.Further complications have not been reported.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed due to pain, nonspecific fatigue, issues with vision, malaise, elevated metal ions.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 the cup and the head, but not for the sleeve.This failure will continue to be monitored for the cup.This will continue to be monitored via routine trending for the head and the sleeve, 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.It should be noted a 62 mm bhr socket was implanted with a 46 mm femoral head.The bhr surgical technique (rev a 01/07 0216-1516) warns to ¿never mix implant colors.Compatible femoral and acetabular components are all the same color.¿ the sizing chart instructs the 62mm (green) acetabular cup is compatible with the 54mm (green) head.The mismatch components cannot be ruled out as a possible contributing factor to the reported elevated metal ions.The patient¿s history of 20 drinks per week cannot be ruled out as a possible contributing factor to his fatigue and malaise.No causal relationship can be confirmed for the reported ¿issues with vision¿ and the implant.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 62MM 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: 18753415
• MDR Text Key: 335911792
• Report Number: 3005975929-2024-00025
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502629
• UDI-Public: 03596010502629
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/30/2012
• Device Catalogue Number: 74120162
• Device Lot Number: 079993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male