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 Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

(b)(6): eu legal case.It was reported that, after a primary bhr-tha construct had been implanted on the patient¿s left hip on (b)(6) 2011, the patient experienced metallosis, elevated metal ion levels, osteolysis, groin pain and ambulation difficulties.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The acetlr cup hap 56mm w/ imptr (case (b)(4)), bhr modular head 50mm (case (b)(4)) and nanos femoral neck prosthesis noncem 6 (case (b)(4)) were explanted.During this procedure, the areas affected by the deposited metal particles were cleaned, and bone grafts were placed on degraded portions of the bone.The plaintiff¿s outcome is unknown.

Manufacturer Narrative

H11: g2 company representative.

Manufacturer Narrative

Sections b3,b4,b7 and e1 were updated due to new information received.

Event Description

*romania - eu legal case* it was reported that, after a primary bhr-tha construct had been implanted on the patient¿s left hip on (b)(6) 2011, the patient experienced metallosis, elevated metal ion levels, osteolysis, groin pain and ambulation difficulties.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The acetlr cup hap 56mm w/ imptr, bhr modular head 50mm and nanos femoral neck prosthesis noncem 6 were explanted.During this procedure, the areas affected by the deposited metal particles were cleaned, and bone grafts were placed on degraded portions of the bone.The patient stated that his health has substantially improved, and that he has recovered about 80% of the mobility without pain or noise around the prosthesis.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.During the revision, the acetlr cup hap 56mm w/ imptr, bhr modular head 50mm and nanos femoral neck prosthesis noncem 6 were explanted.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.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.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.A review of the historical complaints data for the modular head 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 similar complaints were identified to involve this batch and for the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.A review of the historical complaints data for the modular sleeve 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.Other similar complaints were identified for the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Modular heads and modular sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.The available medical documents were reviewed.The reported groin pain, elevated metal ion levels, osteolysis, and black material may be consistent with findings associated with metallosis.However, based on the limited information provided, the clinical root cause of the reported events cause cannot be confirmed.It cannot be concluded that the clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the pain, ambulation difficulty, and revision cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this 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 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: 12573766
• MDR Text Key: 274712409
• Report Number: 3005975929-2021-00462
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 11EW04671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 09/20/2021; 09/20/2021; 10/28/2021; 12/17/2021
• Supplement Dates FDA Received: 10/08/2021; 10/11/2021; 11/09/2021; 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 62 YR