MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM DETACHABLE RASP 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 75004646

Device Problem Material Deformation (2976)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, after reaming with the polarstem detachable rasp 5 and implanting the size 5 stem, the patient experienced a proximal femur crack, requiring the placement of a cable around the fracture site.Subsequently, after reaming with the polarstem detachable rasp 6 and implanting the size 6 stem, the patient experienced a distal femur fracture, requiring the use of a cable to secure the fracture.Both rasps were found to be dull, and they were compacting instead of cutting as intended.The procedure was resumed, after a significant delay, using the same devices.The patient's current health status is unknown.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that, during a total hip replacement surgery, after reaming with the polarstem detachable rasp 5 and implanting the size 5 stem, the patient experienced a proximal femur crack, requiring the placement of a cable around the fracture site.Subsequently, after reaming with the polarstem detachable rasp 6 and implanting the size 6 stem, the patient experienced a distal femur fracture, requiring the use of a cable to secure the fracture.Both rasps were found to be dull, and they were compacting instead of cutting as intended.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to insufficient information it is not possible to perform a review of past corrective actions.As the batch number is unknown, it is not possible to perform a complaint history review at batch level, and the complaint history review based on the product number revealed 5 additional similar complaints.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of the current revision was conducted and it revealed that the instructions for use (lit.No.12.23, ed.03/21) states "hip fracture" as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.The instructions for use indicate to perform a visual inspection pre- and post-usage to ensure instruments are not worn or damaged and are in working order.Based on the information provided, both rasp instruments used were ¿dull and¿were compacting instead of cutting as intended¿ and resulted in proximal and distal femoral bone fractures; therefore, it is likely the instructions for use was not adhered to, and a user/procedural variance is likely a contributing factor to the reported events.The patient impact includes the reported proximal and distal femoral bone fractures with subsequent cabling and a significant surgical delay.A post-surgical restorative phase would be anticipated; however, additional post-op precautions or prolonged recovery phase may be required due to the femoral fractures.Further impact cannot be concluded with certainty; however, the intra-operative bone fractures may place the patient at an increased risk for early/additional interventions and/or possible revision.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARSTEM DETACHABLE RASP 5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19153939
• MDR Text Key: 340728137
• Report Number: 9613369-2024-00042
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996097535
• UDI-Public: 07611996097535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 75004646
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention