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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PRESS-FIT STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS PRESS-FIT STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIA. 13 MM LG 125 135°
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 03/20/2019
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 aseptic glenoid loosening 11 years after primary surgery.Subject id: (b)(6).
 
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Brand Name
AEQUALIS PRESS-FIT 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 Key8508787
Report Number3000931034-2019-00052
Device Sequence Number19245320
Product Code KWS
UDI-Device Identifier03700386915826
UDI-Public03700386915826
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K980244
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/21/2019
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 Health Professional
Device Model NumberDIA. 13 MM LG 125 135°
Device Catalogue NumberDWB733
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2019
Initial Report FDA Received Date04/12/2019
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 Age83 YR
Patient Weight86
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