MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Pain (1994); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after right bhr-tha surgery was performed on (b)(6) 2007, the patient experienced increased pain, swelling, adverse local tissue reaction, elevated metal ions levels and pseudotumor anteriorly.This adverse event was treated with a revision surgery on (b)(6) 2021.During the surgery, the hemi head and the modular sleeve were explanted.Patient's current health status is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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 acetabular cup was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch.No other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode, and this will continue to be monitored.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.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.It should be noted the acetabular component was impacted into its final position in 40 degrees abduction inclination and 50 degrees anteversion.The surgical technique ((b)(4)) indicates, ¿the acetabular component is then fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ it is unknown if the increased anteversion of the acetabular component led to accelerated wear and the elevated metal ions, adverse tissue reaction and corrosion at the head trunnion interface.It cannot be concluded the reported events/ clinical reactions were associated with an implant malperformance or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information 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.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.

Manufacturer Narrative

H6: health effect - clinical code.

• Brand Name: ACETLR CUP HAP 56MM 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: 14545096
• MDR Text Key: 292955634
• Report Number: 3005975929-2022-00368
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 078051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MODULAR SLEEVE -4MM 12/14. LOT#:07FW11732.; SYN POR FEM COMP SZ 18. LOT#:03AM03954.
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 54 YR
• Patient Sex: Male