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

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

Patient Problem Joint Dislocation (2374)

Event Date 02/04/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Internal complaint reference: (b)(4).

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
• Type of Device: 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
• MDR Text Key: 286056250
• Report Number: 9613369-2022-00037
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118605
• UDI-Public: 07611996118605
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention