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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN TORNIER GLENOID IMPLANT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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TORNIER S.A.S. UNKNOWN TORNIER GLENOID IMPLANT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number UNK_WTM
Device Problem Loss of Osseointegration (2408)
Patient Problem Failure of Implant (1924)
Event Date 11/01/2022
Event Type  Injury  
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient has a total shoulder replacement consisting of a humeral side and glenoid side.Unfortunately, the glenoid implant is now loosened and the surgeon would like to revise the poly.The humeral side needs a replacement of the head.The surgeon will remove the loosened poly and replace it with an arthrex equivalent whilst keeping the tornier humeral implant in the patient.
 
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Brand Name
UNKNOWN TORNIER GLENOID IMPLANT
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
Manufacturer (Section G)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR   38330
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15983079
MDR Text Key305488858
Report Number3000931034-2022-00384
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/14/2022
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
Device Operator Lay User/Patient
Device Catalogue NumberUNK_WTM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2022
Initial Date FDA Received12/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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