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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQ ASCEND FLEX STD HUMERAL STEM 7A ANGLE 127 DEGREES5 L.90 PTC; PROSTHESIS SHOULDER JOINT METAL
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TORNIER S.A.S. AEQ ASCEND FLEX STD HUMERAL STEM 7A ANGLE 127 DEGREES5 L.90 PTC; PROSTHESIS SHOULDER JOINT METAL Back to Search Results
Model Number STEM 7A ANGLE 127 DEGREES5 L.90 PTC
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/22/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Not returned to manufacturer.
 
Event or Problem Description
Primary surgery was performed on (b)(6) 2016.On (b)(6) 2017, revision surgery for infection was performed (conversion of the reverse shoulder arthroplasty (rsa) to hrp.All tornier components were removed.
 
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Brand Name
AEQ ASCEND FLEX STD HUMERAL STEM 7A ANGLE 127 DEGREES5 L.90 PTC
Common Device Name
PROSTHESIS SHOULDER JOINT METAL
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
MDR Report Key11942444
Report Number3000931034-2021-00269
Device Sequence Number11818879
Product Code KWS
UDI-Device Identifier03700386944659
UDI-Public03700386944659
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2021
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 Lay User/Patient
Device Model NumberSTEM 7A ANGLE 127 DEGREES5 L.90 PTC
Device Catalogue NumberDWF607A
Device Lot NumberAA0337
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/10/2021
Initial Report FDA Received Date06/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
Patient Weight88
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