MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 75100467

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery performed on (b)(6) 2023, post-op x-ray and ct scans were performed on (b)(6) 2023, it was determined that the patient's implant was mal positioned as a result of a previous nonunion of a femoral fracture.This adverse event was treated via revision surgery on (b)(6) 2023, in which a polar-stem std ti/ha 4 non-cem was exchanged.Patient's current health status is unknown.

Manufacturer Narrative

Section h3, h6: it was reported that, after a total hip replacement surgery performed on (b)(6) 2023, post-op x-ray and ct scans were performed on (b)(6) 2023, it was determined that the patient's implant was mal positioned as a result of a previous nonunion of the femoral fracture.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a polarstem stem std ti/ha 4 non-cem and a oxinium fem hd 12/14 36 mm +0 were exchanged.The device used in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and one additional similar complaint for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use(lit.No.12.23, ed.03/21) states "hip fracture" as a ¿potential adverse device effect¿ and "implant component migration" as a "potential medical device problem" 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.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Specific factors known to contribute to the alleged fault are unreasonable stress on replacement system and trauma to the joint replacement.There is no need for further actions.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.H6: health effect - clinical code and health effect - impact code.

• Brand Name: POLARSTEM STEM STD TI/HA 4 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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: 17803106
• MDR Text Key: 324111203
• Report Number: 9613369-2023-00192
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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: 75100467
• Device Lot Number: C2225788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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
• Treatment: 71343600/23BM11985/OXINIUM FEM HD 12/14 36 MM +0.
• Patient Outcome(s): Required Intervention