ALTIVATE SHOULDER 520-50-218

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-31 for ALTIVATE SHOULDER 520-50-218 manufactured by Encore Medical L.p..

Event Text Entries

[146719024] The reason for this revision surgery was due to dislocation. The previous surgery and the revision detailed in this investigation occurred over 3 months apart. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to dislocation. There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event. There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient age, patient activities, inadequate soft tissue, excessive range-of-motion, excessive load or trauma. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10


[146719025] Revision surgery - due to dislocation per sizing. The surgeon revised to a total.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2019-00499
MDR Report Key8660146
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-05-31
Date of Report2019-05-31
Date of Event2019-05-02
Date Mfgr Received2019-05-02
Device Manufacturer Date2018-11-29
Date Added to Maude2019-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN TX 787585445
Manufacturer CountryUS
Manufacturer Postal787585445
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN TX 787585445
Manufacturer CountryUS
Manufacturer Postal Code787585445
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALTIVATE SHOULDER
Generic NameALTIVATE ANATOMIC, NEUTRAL HUMERAL HEAD, 50X18
Product CodePAO
Date Received2019-05-31
Model Number520-50-218
Catalog Number520-50-218
Lot Number949U1050
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN TX 787585445 US 787585445


Patients

Patient NumberTreatmentOutcomeDate
15201. Required No Informationntervention 2019-05-31

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