MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM DETACHABLE RASP 01; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 75023019

Device Problem Material Deformation (2976)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a thr surgery, the patient experienced a fracture of the femur due to the dullness of one (1) polarstem detachable rasp 01, which failed to properly broach the bone due to compacting.It is unknown how this adverse event was treated.The procedure was resumed after a significant delay, using the same device.The patient's current health status is unknown.

Manufacturer Narrative

H3, h6: it was reported that during a total hip replacement surgery, the patient experienced a fracture of the femur due to the dullness of one (1) polarstem detachable rasp 3, which failed to properly broach the bone due to compacting.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 6 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.No clinically sufficient data was provided to perform a medical investigation.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.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.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.Additional information: d5, d7a, d8, g2, h8 corrected data: b2, b5, h6 (health effect - impact code).

Event Description

It was reported that during a thr surgery, the patient experienced a fracture of the femur due to the dullness of one (1) polarstem detachable rasp 3, which failed to properly broach the bone due to compacting.This adverse event was treated by using an accord cable.The procedure was resumed after a significant delay, using the same device.The patient's current health status is unknown.

• Brand Name: POLARSTEM DETACHABLE RASP 01
• 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: 19154065
• MDR Text Key: 340729384
• Report Number: 9613369-2024-00044
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996111941
• UDI-Public: 07611996111941
• 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: 75023019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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