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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS RESURFACING HEAD; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS RESURFACING HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number HUMERAL HEAD 43X16MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 05/07/2018
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 for loosening/lysis at 8 years post-operative.(b)(6).
 
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Brand Name
AEQUALIS RESURFACING 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 Key7560079
Report Number3000931034-2018-00078
Device Sequence Number19279753
Product Code KWS
UDI-Device Identifier03700386926945
UDI-Public03700386926945
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K062661
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/09/2018
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 NumberHUMERAL HEAD 43X16MM
Device Catalogue NumberDWD804
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2018
Initial Report FDA Received Date06/01/2018
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 Age61 YR
Patient Weight64
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