MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120146
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	12/07/2010
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 total hip arthroplasty (tha) revision surgery on the right hip on (b)(6) 2008.The patient experienced the presence of a pseudotumor dehiscence of the deep tissues from the hip to the vertical cup.This complication was treated by conducting a second revision surgery on (b)(6) 2010.During the procedure, it was encountered a pseudocyst filled with fluid and metal.Trochanter appeared to be deficient, and the muscles were atrophic and scarred.Also, the acetabular cup was somewhat open.The acetabular cup, modular head and modular sleeve were explanted.The patient was taken to the recovery room in stable condition.
Additional Manufacturer Narrative
H3, h6: it was reported that the patient underwent a total hip arthroplasty revision surgery on the right hip.The patient experienced the presence of a pseudotumor dehiscence of the deep tissues from the hip to the vertical cup.This complication was treated by conducting a second revision surgery.During the procedure, it was encountered a pseudocyst filled with fluid and metal.Trochanter appeared to be deficient, and the muscles were atrophic and scarred.Also, the acetabular cup was somewhat open.The acetabular cup, modular head and modular sleeve were explanted.The patient was taken to the recovery room in stable condition.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.No other similar complaints have been identified for the head, cup and sleeve.This will continue to be monitored via routine trending, however it should be noted that this device is 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.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degree inclination angle.However, the operative report¿s indication that the acetabular component was ¿somewhat open¿ and the postoperative diagnosis notates the cup as being vertical.It is unknown if this position of the acetabular component was a migration since implantation and if led to accelerated wear and the pseudocyst, atrophic and scarred trochanter muscles, visible disease and metallosis, and dehisced tensor fascia lata noted intraoperatively.Based on the limited information provided, the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond revision cannot be determined.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 46MM W/ IMPTR
• 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: 17687756
• Report Number: 3005975929-2023-00138
• Device Sequence Number: 12370813
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 3596010502544
• 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: 2005
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Expiration Date: 01/31/2010
• Device Catalogue Number: 74120146
• Device Lot Number: 50633
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/05/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BHR SLVD MODULAR HEAD 38MM; MODULAR SLEEVE -4MM 12/14; SYN POR FEM COMP SZ 11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female