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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

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ENCORE MEDICAL L.P ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM Back to Search Results
Catalog Number 520-08-021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/25/2023
Event Type  Injury  
Event Description
Revision surgery - infection.
 
Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01522; 520-12-000, (b)(4)- 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
ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2
Type of Device
PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL L.P
9800 metric blvd
austin TX 78758
Manufacturer Contact
james mcmahon
9800 metric blvd
austin, TX 78758
MDR Report Key17971374
MDR Text Key326123404
Report Number1644408-2023-01478
Device Sequence Number1
Product Code PKC
UDI-Device Identifier00190446648314
UDI-Public00190446648314
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193226
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/19/2023
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
Device Operator Health Professional
Device Catalogue Number520-08-021
Device Lot Number1924A1200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/19/2023
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
Treatment
520-54-218 LOT: 950U1076
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient SexMale
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