MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	75018402
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The complaint sample was not returned.No product evaluation could be performed.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of the product documentation did not detect any deviation that could have contributed to the reported 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.A review of the device labeling revealed that the ifu (81114321 rev.A) states bone fracture(s) as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.Based on the available information and the performed investigation, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.The root cause of the reported event remains therefore undetermined.The need for further actions is not indicated.This investigation is considered closed.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this device for similar issues.
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2024, the patient experienced periprosthetic fracture.This adverse event was treated by a revision surgery on (b)(6) 2024, in which a polarstem collar std.Ti/ha 2 was exchanged with a redapt stem and cable.Patient left surgery in good health.No further complications were reported.
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2024, where the implanted stem was undersized, the patient experienced periprosthetic fracture.This adverse event was treated by a revision surgery on (b)(6) 2024, in which a polarstem collar std.Ti/ha 2 was exchanged with a redapt stem and cable.Patient left surgery in good health.No further complications were reported.
Additional Manufacturer Narrative
Corrected data: b5, h6 (medical device problem code).

• Brand Name: POLARSTEM COLLAR STD. TI/HA 2
• Common Device Name: 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: 20558074
• Report Number: 9613369-2024-00140
• Device Sequence Number: 13010830
• Product Code: LWJ
• UDI-Device Identifier: 07611996103397
• UDI-Public: 7611996103397
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 75018402
• Device Lot Number: C2407609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male