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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM; PROSTHESIS SHOULDER JOINT METAL
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TORNIER INC PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM; PROSTHESIS SHOULDER JOINT METAL Back to Search Results
Model Number PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/12/2021
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
Post-operative complication : infection.Re-operation with component change on the (b)(6) 2021 (no information regarding the exact devices removed).Iv antibiotics, cement antibiotic spacer added.
 
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Brand Name
PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM
Common Device Name
PROSTHESIS SHOULDER JOINT METAL
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
MDR Report Key12297947
Report Number3004983210-2021-00059
Device Sequence Number3806941
Product Code KWS
UDI-Device Identifier00846832061907
UDI-Public00846832061907
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K161742
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 08/09/2021
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 NumberPERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM
Device Catalogue NumberDWJ013
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date08/09/2021
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 Weight72
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