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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II BASE PLATE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED II BASE PLATE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DWD067
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 07/18/2017
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 is facing an instability-dislocation.Patient dislocated shoulder and has had issues with instability since.X-rays show broken inferior screw on glenoid.Patient will undergo a revision surgery to fix instability issues.Patient id : (b)(6).
 
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Brand Name
AEQUALIS REVERSED II BASE PLATE
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 Key6806691
Report Number3000931034-2017-00154
Device Sequence Number149669
Product Code KWS
UDI-Device Identifier03700386928239
UDI-Public03700386928239
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K061439
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/27/2017
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 Expiration Date08/27/2020
Device Model NumberDWD067
Device Catalogue NumberDIAM. 29MM LONG POST
Device Lot Number3509AQ
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 07/27/2017
Initial Report FDA Received Date08/21/2017
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 Age68 YR
Patient Weight131
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