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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number LATERALIZED D42MM TH. +6MM
Medical Device Problem Code Material Erosion (1214)
Health Effect - Clinical Codes Extraskeletal ossification (1428); 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 due to heterotopic ossification and humeral component wear, 8 years post-operative.Patient id: (b)(6).
 
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Brand Name
AEQUALIS REVERSED INSERT
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 Key8199070
Report Number3000931034-2018-00186
Device Sequence Number13815142
Product Code KWS
UDI-Device Identifier03700386916571
UDI-Public03700386916571
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K050316
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) 11/30/2018
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 No Information
Device Model NumberLATERALIZED D42MM TH. +6MM
Device Catalogue NumberDWB996
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2018
Initial 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 Age59 YR
Patient Weight102
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