MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75100464

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

Patient Problems Bone Fracture(s) (1870); Arthralgia (2355)

Event Date 07/25/2023

Event Type  Injury  

Event Description

It was reported that, after a tha surgery was performed on (b)(6) 2023, the patient experienced pain and a bone fracture around the stem on (b)(6) 2023 as a consequence of a fall.A revision surgery was performed on the (b)(6) 2023 to treat this adverse event in which a polarstem stem std ti/ha 1 non-cem and a oxinium fem hd 12/14 32mm +0 were exchanged while a r3 3 hole acet shell 50mm and a r3 0 deg xlpe acet lnr 32mm x 50mm remained.In addition, the surgeon does not believe that the product is at fault as they were caused by the patient's fall.The current health status of the patient is unknown.

Manufacturer Narrative

Internal reference number: (b)(4).H10: 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.

Manufacturer Narrative

H3, h6.It was reported that, after a total hip arthroplasty surgery, the patient experienced pain and a bone fracture around the stem as a consequence of a fall.A revision surgery was performed to treat this adverse event in which a polarstem stem std ti/ha 1 non-cem and a oxinium fem hd 12/14 32mm +0 were exchanged while a r3 3 hole acet shell 50mm and a r3 0 deg xlpe acet lnr 32mm x 50mm remained.The current health status of the patient is unknown.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 1 additional similar complaints 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 "history of falls" as a "risk factor"; and "hip fracture" and "pain" as ¿potential adverse device effects¿ 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.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.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 1 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 17631062
• MDR Text Key: 322040708
• Report Number: 9613369-2023-00179
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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: Lay User/Patient
• Device Catalogue Number: 75100464
• Device Lot Number: C2215367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/10/2023
• Supplement Dates FDA Received: 09/11/2023
• Date Device Manufactured: 07/20/2022
• 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: 71335550/R3 3 HOLE ACET SHELL 50MM.; 71339550/R3 0 DEG XLPE ACET LNR 32MM X 50MM.; 71343200/OXINIUM FEM HD 12/14 32MM +0.
• Patient Outcome(s): Required Intervention