MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN POLARSTEM CEMENTLESS (TI/HA); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 05/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a total hip replacement was performed in 2019, the patient experienced a breakage of the femoral neck from the polarstem collar.Incident took place on (b)(6) 2022 while the patient was walking and heard a snap, to which of course he was unstable and in pain.This adverse event was treated with revision surgery.Patient's current health status is unknown; however, before this incident, the patient did not have any prior trauma, accidents, or surgery that would impact the integrity of the stem.

Manufacturer Narrative

H3, h6: it was reported that, after a total hip replacement was performed in 2019, the patient experienced a breakage of the femoral neck from the polarstem collar.Incident took place on (b)(6) 2022 while the patient was walking and heard a snap, to which of course he was unstable and in pain.This adverse event was treated with revision surgery.The device was not returned for investigation, but pictures of the fractured polarstem collar device were provided.Based on a visual inspection using the pictures, the reported failure mode can be confirmed.The polarstem is fractured at the proximal neck.However, due to the missing device, a further analysis of the fracture is not possible.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.A product history review could not be performed, as part and batch number are unknown.Due to insufficient information it is not possible to perform a review of past corrective actions.The failure mode and the severity are covered in the corresponding risk management document.A thorough medical evaluation was not possible due to insufficient information available.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.In the smith and nephew instruction for use (ifu lit.No.12.23 ed.03/21), implant component fracture is listed as a potential medical device problem in combination with the implantation of a smith and nephew hip implant.Based on the performed investigations, the relationship between the reported event and the device was confirmed.However, due to insufficient information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution and it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at this time.Smith+nephew will continue to monitor this device for similar issues.

• Brand Name: UNKNOWN POLARSTEM CEMENTLESS (TI/HA)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 14599410
• MDR Text Key: 293335095
• Report Number: 9613369-2022-00269
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2022
• Initial Date FDA Received: 06/04/2022
• Supplement Dates Manufacturer Received: 05/15/2022; 07/22/2022
• Supplement Dates FDA Received: 07/14/2022; 07/27/2022
• 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; Hospitalization
• Patient Sex: Male