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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number DWF361B
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
 
Event or Problem Description
It was reported that the patient had a post-operative complication with instability and dislocation of the device in the shoulder.The patient underwent a revision surgery with a component change.
 
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Brand Name
FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B
Common Device Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
MDR Report Key12298372
Report Number3000931034-2021-00299
Device Sequence Number4490383
Product Code KWS
UDI-Device Identifier03700386940507
UDI-Public03700386940507
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/09/2021
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? Yes
Operator of Device Lay User/Patient
Device Model NumberDWF361B
Device Catalogue NumberDWF361B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date08/09/2021
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 Required Intervention;
Patient Age80 YR
Patient Weight70
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