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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIA. 12MM LG 115MM 130°
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event 12/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
 
Event or Problem Description
It was reported that a patient underwent a revision surgery due to loosening/lysis, 15 years after primary surgery.Patient id:(b)(6).
 
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Brand Name
AEQUALIS HUMERAL STEM
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
MDR Report Key11153627
Report Number3000931034-2021-00004
Device Sequence Number3940278
Product Code KWS
UDI-Device Identifier03700386915239
UDI-Public03700386915239
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K952928
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/14/2020
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 NumberDIA. 12MM LG 115MM 130°
Device Catalogue NumberDWB122
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2020
Initial Report FDA Received Date01/12/2021
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 Age68 YR
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