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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 12.5/B; PROSTHESIS SHOULDER JOINT POLYMER
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TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D42 TH+9 STD ANGLE 12.5/B; PROSTHESIS SHOULDER JOINT POLYMER Back to Search Results
Model Number REVERVED INSERT D42 TH+9 STD ANGLE 12.5/B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/15/2021
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 was diagnosed with a periprosthetic infection 6 weeks after initial surgery.Re-operation without component change (irrigation and debridement, medication iv daptomycin and now chronic suppression with doxycycline).
 
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Brand Name
FLEX SHOULDER SYSTEM REV INSERT D42 TH+9 STD ANGLE 12.5/B
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 Key12304992
Report Number3000931034-2021-00304
Device Sequence Number19826026
Product Code KWS
UDI-Device Identifier03700386940897
UDI-Public03700386940897
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 Year2020
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/10/2021
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 NumberREVERVED INSERT D42 TH+9 STD ANGLE 12.5/B
Device Catalogue NumberDWF422B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/15/2021
Initial Report FDA Received Date08/10/2021
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 Age83 YR
Patient Weight74
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