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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number DIAM 42MM TH+9MM A 12.5B
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Date of Event 03/06/2019
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 anterosuperior escape, 1 year after primary surgery.Subject id: (b)(6)".
 
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Brand Name
AEQUALIS ASCEND FLEX 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 Key8716316
Report Number3000931034-2019-00098
Device Sequence Number2022286
Product Code KWS
UDI-Device Identifier03700386940897
UDI-Public03700386940897
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/07/2019
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 Lay User/Patient
Device Expiration Date06/30/2020
Device Model NumberDIAM 42MM TH+9MM A 12.5B
Device Catalogue NumberDWF422B
Device Lot Number8935AP
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2019
Initial Report FDA Received Date06/20/2019
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 Age75 YR
Patient Weight100
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