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

Catalog Number 74120156

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 04/15/2016

Event Type  Injury  

Event Description

*us legal* it was reported that, after a metal on metal construct had been implanted on the plaintiff's left hip on (b)(6) 2012, the plaintiff experienced pain.A revision surgery was performed on (b)(6) 2016 to treat this adverse event.The plaintiff outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a manufacturing record, complaint history and device labelling / ifu review could not be performed.All marts would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Based on the reported symptom it cannot be concluded that the events/clinical reaction (pain) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that in a bilateral patient.After a metal on metal construct had been implanted on the patient's left hip on (b)(6) 2012, the patient experienced pain and metallosis.A revision surgery was performed on (b)(6) 2016 to treat this adverse event.The patient outcome is unknown.

Manufacturer Narrative

Sections b4, b5 and b7 were updated due to new information received.

Event Description

It was reported that, after a metal on metal construct had been implanted on the patient left hip on (b)(6) 2012, the plaintiff experienced pain, metallosis and swelling around the iliopsoas tendon and the hip abductors with no evidence of tendon disruption as revealed by mri.A revision surgery was performed on (b)(6) 2016 to treat this adverse event.The plaintiff recovered well from the procedure.

Manufacturer Narrative

It was reported that revision surgery was performed on the patient¿s left hip.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.A review of the historical complaints data for the cup, head and modular sleeve was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for the cup or sleeve.A search was also made using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints have been identified for the cup.This will continue to be monitored.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for the modular sleeve.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical information was reviewed.With the information provided the clinical root cause of the reported pain and metallosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain and revision cannot be determined at this time.Without additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed due to experienced pain, metallosis and swelling in a bilateral patient.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 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 acetabular cup, this will continue to be monitored.In the absence of the actual device, 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 product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.With the information provided the clinical root cause of the reported pain and metallosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 device 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 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: 11934430
• MDR Text Key: 254273137
• Report Number: 3005975929-2021-00305
• Device Sequence Number: 1
• Product Code: NXT
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Catalogue Number: 74120156
• Device Lot Number: 12BW35933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 71932824, SHORT TAPERED STEM PC STD SZ8,12FM09950.; 74222200, MODULAR SLEEVE PLUS 0MM12/14, 09BW21808.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male