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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM. 48MM HEIGHT 18MM
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 04/22/2019
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 due to gross loosening of glenoid component, 10 years after primary surgery.Subject id: (b)(6)".
 
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Brand Name
AEQUALIS 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 Key8611450
Report Number3000931034-2019-00077
Device Sequence Number11263572
Product Code KWS
UDI-Device Identifier03700386915543
UDI-Public03700386915543
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K994392
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/30/2019
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 Date04/28/2014
Device Model NumberDIAM. 48MM HEIGHT 18MM
Device Catalogue NumberDWB248
Device Lot Number0886AH
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/30/2019
Initial Report FDA Received Date05/15/2019
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 Age81 YR
Patient Weight73
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