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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 41X15 MM ECC 3.5 COCR
Medical Device Problem Codes Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes Muscle Weakness/Atrophy (1967); Reaction (2414)
Date of Event 10/31/2018
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 revision surgery 4 years post-operative due to an allergy to nickel combined with glenoid loosening and cuff failure.Patient id: (b)(6).
 
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Brand Name
AEQUALIS ASCEND FLEX HUMERAL HEAD
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 Key8137240
Report Number3000931034-2018-00185
Device Sequence Number16580754
Product Code KWS
UDI-Device Identifier03700386940156
UDI-Public03700386940156
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 Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/08/2018
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 No Information
Device Expiration Date03/31/2019
Device Model Number41X15 MM ECC 3.5 COCR
Device Catalogue NumberDWF141
Device Lot Number0250AO
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2018
Initial Report FDA Received Date12/06/2018
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 Age47 YR
Patient Weight57
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