MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 6 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100469
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2022 the patient experienced dislocation due to the components being placed in a sub-optimal position.This adverse event was solved by revision surgery to explant the complete system on (b)(6) 2022.The physician revised a polarstem stem std ti/ha 6 non-cem.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
It was reported that, after thr surgery had been performed on (b)(6) 2022 the patient experienced dislocation due to the components were placed in a sub optimal position.This adverse event was solved by revision surgery to explant the complete system on (b)(6) 2022.Dr.(b)(6) revised with redapt stem, redapt cup and or3o liner/insert.Current health status of patient is unknown.The complaint device polarstem stem std ti/ha 6 non-cem (art.No.(b)(4), lot no.B1706341), used in treatment, was not returned for investigation hence the product evaluation could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.The ifu (lit.No.12.23, ed.03/21) stated joint dislocation among possible side effects resulting from hip arthroplasty.No further clinical documentation was available hence a thorough medical investigation cannot be performed.The surgical technique states that the final position of the acetabular component should be approximately 45 degrees of abduction and 20 degrees of anteversion or at the surgeon¿s desired acetabular cup orientation.No further medical assessment can be rendered at this time.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.This version of the device will be monitored for similar issues.This investigation is considered closed.Should the complaint device become available, the complaint will be reassessed.Internal complaint reference: case (b)(4).

• Brand Name: POLARSTEM STEM STD TI/HA 6 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: 13591087
• Report Number: 9613369-2022-00037
• Device Sequence Number: 6061798
• Product Code: LWJ
• UDI-Device Identifier: 07611996118605
• UDI-Public: 07611996118605
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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 Expiration Date: 04/26/2024
• Device Model Number: 75100469
• Device Catalogue Number: 75100469
• Device Lot Number: B1706341
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown