MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 2 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-PORO, UNCEMENT

Model Number	75100465
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2022, a femoral fracture extending to the distal tip of the primary hip stem was noticed after x-ray and examination.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a polarstem stem std ti/ha 2 non-cem and oxinium fem hd 12/14 36 mm l/+8 were exchanged with a smith & nephew revision hip stem, femoral head, and several cables.Patient's current health status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that, after a thr surgery was performed on (b)(6) 2022, a femoral fracture extending to the distal tip of the primary hip stem was noticed after x-ray and examination.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a polarstem stem std ti/ha 2 non-cem and oxinium fem hd 12/14 36 mm l/+8 were exchanged with a smith&nephew revision hip stem, femoral head, and several cables.Patient's current health status is unknown.The device intended for use 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 performed complaint history review for the complaint device revealed no previous complaints for the same batch.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 "implant component fracture" of the component as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed, the performed investigation do not lead to an accurately determined cause.There is no objective evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about 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.

• Brand Name: POLARSTEM STEM STD TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-PORO, UNCEMENT
• 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: 15875770
• Report Number: 9613369-2022-00600
• Device Sequence Number: 2479865
• Product Code: LZO
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: C2200377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71343608/OXINIUM FEM HD 12/14 36 MM L/+8.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female