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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II BASEPLATE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED II BASEPLATE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM 29MM L30MM PTC COATING
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
"it was reported that a patient underwent a revision surgery for glenoid implant breakage, 4 years post-operative.Patient id: (b)(6).".
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
AEQUALIS REVERSED II BASEPLATE
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 Key7486530
Report Number3000931034-2018-00063
Device Sequence Number10812090
Product Code KWS
UDI-Device Identifier03700386952739
UDI-Public03700386952739
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K132285
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,Followup
Report Date (Section B) 04/05/2018
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 Physician
Device Expiration Date05/31/2019
Device Model NumberDIAM 29MM L30MM PTC COATING
Device Catalogue NumberDWE830
Device Lot Number1217AO
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/05/2018
Supplement Date Received by Manufacturer04/05/2018
Initial Report FDA Received Date05/04/2018
Supplement Report FDA Received Date12/27/2018
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 Age60 YR
Patient Weight107
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