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

Model Number	75100464
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tha performed on (b)(6) 2018, periprosthetic fracture occurred around the polarstem stem std ti/ha 1 non-cem on (b)(6) 2018.A revision surgery was performed on (b)(6) 2018 to solve the issue, the stem was exchanged for a cemented stem.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a total hip arthroplasty performed on (b)(6) 2018, periprosthetic fracture occurred around the polarstem stem std ti/ha 1 non-cem on 08-jun-2018.A revision surgery was performed on (b)(6) 2018 to solve the issue, the stem was exchanged for a cemented stem.Patient's current health is recovered.The complaint device used in treatment was not returned for investigation.A visual evaluation was not possible, so the mentioned failure mode is not confirmed.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 and severity of the reported issue.A review of the device labeling revealed that the instructions for use document (lit.No.Lit.No.12.23, ed.03/21) states hip fracture as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.Based on the performed investigations, the relationship between the reported event and the device was not confirmed.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.The need for corrective action is not indicated.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
• 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: 15544503
• Report Number: 9613369-2022-00559
• Device Sequence Number: 6575750
• Product Code: LWJ
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B1715130
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 66 KG