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 Bone Fracture(s) (1870); Osteolysis (2377); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2007, the patient experienced pain localized in the groin area and center of the left buttock, leg length discrepancy of approximately 5mm, elevated metal ion levels, adverse reaction to metallic debris, osteolysis of the proximal femur and retroacetabular region and pathologic intertrochanteric fracture at the tip of the resurfacing head.A revision surgery was conducted on (b)(6) 2019 to treat this adverse event.During this procedure, both the bhr acetabular cup and femoral resurfaced head were explanted and replaced with a competitor¿s thr system.The patient¿s outcome is not known.

Manufacturer Narrative

It was reported that a left hip bhr revision surgery was performed due to pain, leg length discrepancy, elevated metal ion levels, adverse reaction to metallic debris, osteolysis and pathologic intertrochanteric fracture.The devices, used in treatment, were not returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the devices concerned.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the acetabular cup and similar complaints have been identified for the femoral head.This failure will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review 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.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.Although the reported pain, elevated metal ions, pseudocapsule, dark staining and metallic staining may be consistent with the reported ¿adverse reaction to metallic debris¿ the clinical root cause of the reported events/ clinical reactions cannot confirmed.However, it should be noted the surgical technique for bhr (01/07 4567-0103) indicates, the acetabular component is to be fully impacted with 15-20° of anteversion and 40-45° inclination angle.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the reported adverse reaction to metallic debris and intertrochanteric fracture.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information, including operatory reports, 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.

• 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: 14847074
• MDR Text Key: 295059641
• Report Number: 3005975929-2022-00411
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male