MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122152

Device Problem Biocompatibility (2886)

Patient Problems Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Us legal.It was reported that, after a primary right bhr surgery was performed on (b)(6) 2009 due to degenerative arthritis with mild dysplasia; the plaintiff underwent revision surgery on (b)(6) 2021.The revision surgery was indicated due to failed right bhr secondary, adverse local tissue reaction/metallosis and elevated serum cobalt/chromium ion levels.The status of the plaintiff is unknown.

Manufacturer Narrative

H9: z-2267-2018, z-2268-2018, z-2745-2015 through z-2747-2015.H3, h6: it was reported that a 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 femoral head and 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.Other complaints were identified to involve the femoral head and acetabular cup batch number.Furthermore, other similar complaints were identified for the part number and the reported/related failure mode of the femoral head and the acetabular cup.However, as the devices are no longer sold, no action is to be taken.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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions 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 degrees of abduction.However, the implantation operative report indicated the acetabular component was impacted at about 25 degrees of anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the reported elevated cobalt and chromium levels, massive, brown-tinged fluid collection and destruction of the anterior and lateral hip capsule noted intraoperatively.Based on the information provided, the 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 or implant failure.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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.

• Brand Name: ACETABULAR CUP HAP SIZE 44/52
• 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: 14504088
• MDR Text Key: 292699148
• Report Number: 3005975929-2022-00342
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 3596010552280
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 74122152
• Device Lot Number: 08GW17671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: REFER TO H10
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female