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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENOVRE MEDICAL L.P. DJO SURGICAL; ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS
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ENOVRE MEDICAL L.P. DJO SURGICAL; ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS Back to Search Results
Catalog Number 521-07-250
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/11/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Revision surgery - due to infection.
 
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2022-01510; 521-07-250, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
 
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Brand Name
DJO SURGICAL
Common Device Name
ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS
Manufacturer (Section D)
ENOVRE MEDICAL L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENOVRE MEDICAL L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
stacey bonnell
9800 metric blvd
austin, TX 78758
5128346313
MDR Report Key20873936
Report Number1644408-2024-01862
Device Sequence Number18368892
Product Code PAO
UDI-Device Identifier00190446178385
UDI-Public00190446178385
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K162024
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/07/2024
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 Health Professional
Device Expiration Date01/30/2024
Device Catalogue Number521-07-250
Device Lot Number893U1124
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2024
Initial Report FDA Received Date12/07/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured02/04/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
520-07-000 LOT: 888U1443.; 520-12-000 LOT: 852U1372.; 520-50-320 LOT: 879U1030.
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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