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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Back to Search Results
Catalog Number 75100467
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Insufficient Information (4580)
Event Date 09/04/2023
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, after a thr surgery performed on (b)(6) 2023, post-op x-ray and ct scans were performed on (b)(6) 2023, it was determined that the patient's implant was mal positioned as a result of a previous nonunion of a femoral fracture.This adverse event was treated via revision surgery on (b)(6) 2023, in which a polar-stem std ti/ha 4 non-cem was exchanged.Patient's current health status is unknown.
 
Manufacturer Narrative
Section h3, h6: it was reported that, after a total hip replacement surgery performed on (b)(6) 2023, post-op x-ray and ct scans were performed on (b)(6) 2023, it was determined that the patient's implant was mal positioned as a result of a previous nonunion of the femoral fracture.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a polarstem stem std ti/ha 4 non-cem and a oxinium fem hd 12/14 36 mm +0 were exchanged.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 one additional similar complaint 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 "hip fracture" as a ¿potential adverse device effect¿ and "implant component migration" as a "potential medical device problem" 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.Specific factors known to contribute to the alleged fault are unreasonable stress on replacement system and trauma to the joint replacement.There is no need for further actions.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.H6: health effect - clinical code and health effect - impact code.
 
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Brand Name
POLARSTEM STEM STD TI/HA 4 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 Key17803106
MDR Text Key324111203
Report Number9613369-2023-00192
Device Sequence Number1
Product Code LWJ
UDI-Device Identifier07611996118582
UDI-Public07611996118582
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/19/2023
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 Health Professional
Device Catalogue Number75100467
Device Lot NumberC2225788
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/04/2023
Initial Date FDA Received09/22/2023
Supplement Dates Manufacturer Received10/18/2023
Supplement Dates FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
71343600/23BM11985/OXINIUM FEM HD 12/14 36 MM +0.
Patient Outcome(s) Required Intervention;
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