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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 D42 TH+9 STD ANGLE 17.5/A; PROSTHESIS SHOULDER JOINT POLYMER
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TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D42 TH+9 STD ANGLE 17.5/A; PROSTHESIS SHOULDER JOINT POLYMER Back to Search Results
Model Number INSERT D42 TH+9 STD ANGLE 17.5/A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/22/2017
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
Primary surgery was performed on (b)(6) 2016.On (b)(6) 2017, revision surgery for infection was performed (conversion of the reverse shoulder arthroplasty (rsa) to hrp.All tornier components were removed.
 
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Brand Name
FLEX SHOULDER SYSTEM REV INSERT D42 TH+9 STD ANGLE 17.5/A
Common Device Name
PROSTHESIS SHOULDER JOINT POLYMER
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
MDR Report Key11942485
Report Number3000931034-2021-00270
Device Sequence Number17200338
Product Code KWS
UDI-Device Identifier03700386940880
UDI-Public03700386940880
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2021
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? No
Operator of Device Lay User/Patient
Device Model NumberINSERT D42 TH+9 STD ANGLE 17.5/A
Device Catalogue NumberDWF422A
Device Lot Number7542AN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/10/2021
Initial Report FDA Received Date06/04/2021
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 Age76 YR
Patient Weight88
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