MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Loss of Osseointegration (2408); Biocompatibility (2886); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Discomfort (2330); Joint Dislocation (2374); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530); Unequal Limb Length (4534); Implant Pain (4561)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that, after a bhr construct had been implanted on (b)(6) 2012 in the right hip, the patient experienced pain, limited mobility, metallosis, elevated metal ion levels, loosening of implant, and memory impairment.A revision surgery was performed on the (b)(6) 2020 to address the adverse event.The patient outcome is unknown.

Manufacturer Narrative

As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H10: additional information in a2, b5, b6, d1, d4 and h4.H11: corrected information in h6 (health effect - clinical code, health effect - impact code and medical device problem code).

Event Description

It was reported that a revision surgery was performed on the patient right hip on the (b)(6) 2020 due to pain, limited mobility, metallosis, elevated metal ion levels, loosening of the acetabular component, dislocation, and memory impairment.During the revision, both metallic components were explanted and replaced with a tha system.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed on the patient right hip on the 25(b)(6) 2020 due to pain, limited mobility, metallosis, elevated metal ion levels, loosening of the acetabular component, dislocation, and memory impairment.During the revision, both metallic components were explanted and replaced with a total hip arthroplasty system.The patient outcome is unknown.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 devices concerned 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 for the head.This will continue to be monitored via routine trending, 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.The reported pain, elevated cobalt, squeaking, catching, popping and limping may be consistent with the reported grossly loose acetabular component.However, it cannot be determined to what extent the patients¿ history of bicycle/mva accident and/or her history of running 5-10 miles daily had on her pain and clinical status.The patient impact beyond the reported events cannot be determined; however, it is noted 6-weeks post revision the patient was doing well.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; muscle and fibrous tissue laxity and malpositioning of the implants leading to postoperative joint instability.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.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: ACETLR CUP HAP 50MM 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 ; UK
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire ; UK
• Manufacturer Contact: holly topping ; aurora house; spa park; leamington spa, warwickshire ; UK ; 5123913905
• MDR Report Key: 10853729
• MDR Text Key: 216667364
• Report Number: 3005975929-2020-00451
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 3596010502568
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 088201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2746-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female