MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120148

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 09/18/2017

Event Type  Injury  

Event Description

It was reported that, following a revision surgery performed on the patient¿s right hip on (b)(6) 2017 due to elevated metal ion levels, pain and pseudotumor formation, the patient experienced multiple dislocations and required an additional revision surgery on (b)(6) 2017.During this procedure, the bhr acetabular cup was explanted with the rest of the bearing components (competitors) and replaced with a new shell, a constrained liner and a femoral head.Intraoperatively, severe plastic wear from the dislocated dual mobility liner was identified and a deep subfascial pseudotumor was excised.The patient¿s outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Results of investigation: it was reported that a right hip revision surgery was performed.As of today, the implanted device, which was used in treatment has 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.Other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode.However, as the device is no longer sold, no action is to be taken.In the absence of the actual device, the production records were reviewed for the device 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 product 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.It should be noted during prior revision the smith and nephew acetabular cup was retained and stryker liner, head and stem were implanted.With the information provided the clinical root cause of the pseudotumor, dislocation and subsequent revision cannot be confirmed.However, the mix-manufacturer construct, pelvic tilt, and/or gluteus medius insufficiency cannot be ruled out as contributing factors to reported events/clinical reaction.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided, we can confirm this complaint.The mix-manufacturer construct, pelvic tilt, and/or gluteus medius insufficiency is a possible root cause to the noted multiple dislocations.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, excessive patient weight, trauma to the joint replacement.Should the device or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.Corrected data: h3, h6 (health effect - clinical code, health effect - impact code, medical device problem code).

• Brand Name: ACETLR CUP HAP 48MM 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: 14974283
• MDR Text Key: 295601332
• Report Number: 3005975929-2022-00419
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 3596010502551
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 082790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2008
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female