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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number PTC SIZE 1B, 132.5° 66MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event or Problem Description
(b)(6) 2020: ascend flex reverse surgery was performed.Lately in (b)(6) 2020: signs of infection were found after the surgery.(b)(6) 2021: revision surgery was performed.All the implants were removed, the affected part was cleaned, the spacer made by cement was implanted, and the surgery was completed.
 
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Brand Name
AEQUALIS ASCEND FLEX HUMERAL STEM
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
MDR Report Key12142351
Report Number3000931034-2021-00045
Device Sequence Number3989094
Product Code KWS
UDI-Device Identifier03700386944482
UDI-Public03700386944482
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/26/2021
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 Expiration Date04/08/2025
Device Model NumberPTC SIZE 1B, 132.5° 66MM
Device Catalogue NumberDWF601B
Device Lot NumberCZ2220066
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2021
Initial Report FDA Received Date07/09/2021
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 Other;
Patient Age82 YR
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