ALTIVATE SHOULDER 520-46-216

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 2019-03-15 for ALTIVATE SHOULDER 520-46-216 manufactured by Encore Medical L.p..

Event Text Entries

[138945111] The reason for this revision surgery was due to the humeral head popping off. The previous surgery and the surgery detailed in this investigation occurred 1. 1 year 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, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event. The device was verified to have gone through an acceptable sterilization process and 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 humeral head popping off. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. 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


[138945112] Revision surgery - due to the humeral head popping off due to patient reaching behind her back.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2019-00198
MDR Report Key8425219
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-03-15
Date of Report2019-03-15
Date of Event2018-12-11
Date Mfgr Received2019-03-05
Device Manufacturer Date2017-07-24
Date Added to Maude2019-03-15
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, 46X16
Product CodePAO
Date Received2019-03-15
Model Number520-46-216
Catalog Number520-46-216
Lot Number948U1016
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-03-15

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