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 Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Us legal.It was reported that, after a bhr-tha construct had been implanted on the patient¿s left hip on an unspecified date, the patient developed osteolysis around her pelvis and loosening of the acetabular component following a metallosis diagnosis.A revision surgery was performed on 20-sep-2021 to treat this adverse event.During this procedure, the posterior hip capsule had staining consistent with a gray metallosis, and the joint presented some grayish fluid and significant gray and black staining to the soft tissue.Some osteolysis along the posterior femoral shaft in the metaphyseal region was also noted.Upon removing the bhr modular femoral head and cup, the surgeon faced several difficulties whilst fixing a 56mm acetabular cup and was not satisfied with the outcome, as a properly fixation could had been compromised mainly due to the deficient condition of the medial, anterior and posterior wall of the acetabulum.Because of this, he decided to place the new implants and close the incision to further plan a caged reconstruction of the acetabulum.Patient¿s current health status is unknown.

Manufacturer Narrative

Results of investigation: it was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.Should further details become available at a later date then the task will be reopened and completed.A review of the historical complaints data for the 74121342 modular head 42 mm -4 (short) and the acetabular cup was performed 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/reopen date.No other similar complaints were identified for the part numbers and the reported/related failure modes.However, as the devices are no longer sold, no action is to be taken.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.Should further details become available at a later date then the task will be reopened and completed.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review and historical review of the escalation actions could not be performed.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.The clinical information provided of the gray and black staining to the soft tissue, grayish fluid, osteolysis, loose acetabular component, and bone deficiency may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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.Corrected data: h3.

• 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: 14670344
• MDR Text Key: 293836469
• Report Number: 3005975929-2022-00396
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120148
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/11/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female