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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID KEELED; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS GLENOID KEELED; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number XL SIZE
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 10/24/2017
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 glenoid loosening/lysis, 7 months post-op.(total shoulder arthroplasty on (b)(6) 2004 - diagnostic arthroscopy of the glenohumeral joint on (b)(6) 2004) patient id: (b)(6).".
 
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Brand Name
AEQUALIS GLENOID KEELED
Common Device Name
SHOULDER JOINT POLYMER PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR  38330
MDR Report Key7052189
Report Number3000931034-2017-00205
Device Sequence Number11065594
Product Code KWS
UDI-Device Identifier03700386915444
UDI-Public03700386915444
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K994393
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2017
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 Model NumberXL SIZE
Device Catalogue NumberDWB213
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 10/26/2017
Initial Report FDA Received Date11/22/2017
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 Age77 YR
Patient Weight77
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