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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number STD PTC SIZE 3B
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 09/05/2018
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
It was reported that a patient underwent a surgery with small tuberosity osteotomy (anterior impingement of the prosthesis with the conjoint tendon).The prosthesis was not touched by the surgeon.Patient id: (b)(6).
 
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Brand Name
AEQUALIS ASCEND FLEX REVERSED 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 Key7978030
Report Number3000931034-2018-00144
Device Sequence Number16502579
Product Code KWS
UDI-Device Identifier03700386944543
UDI-Public03700386944543
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/20/2018
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 Health Professional
Device Model NumberSTD PTC SIZE 3B
Device Catalogue NumberDWF603B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2018
Initial Report FDA Received Date10/18/2018
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 Age72 YR
Patient Weight100
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