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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. ASCEND FLEX HEAD LOW OFFSET 43MM X 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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TORNIER S.A.S. ASCEND FLEX HEAD LOW OFFSET 43MM X 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number DWF043
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Codes Granuloma (1876); Foreign Body In Patient (2687)
Date of Event 07/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.
 
Event or Problem Description
It was reported that the patient underwent a shoulder surgery.Sometime post-op, the patient noticed a lump on the anterior shoulder.A ct scan showed metal debris.The patient underwent a revision surgery.
 
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Brand Name
ASCEND FLEX HEAD LOW OFFSET 43MM X 16MM
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 Key12332635
Report Number3000931034-2021-00310
Device Sequence Number2826115
Product Code KWS
UDI-Device Identifier03700386940040
UDI-Public03700386940040
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) 08/17/2021
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 NumberDWF043
Device Catalogue NumberDWF043
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/20/2021
Initial Report FDA Received Date08/17/2021
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 Age53 YR
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