• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REVERSE SHOULDER; STEM, HUMERAL SIZE6 RSP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENCORE MEDICAL L.P. REVERSE SHOULDER; STEM, HUMERAL SIZE6 RSP Back to Search Results
Model Number 508-00-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Swelling (2091)
Event Date 02/08/2012
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported after learning about a potential device related event following a review of clinical study records.The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.
 
Event Description
Reported incident - due to the patient having right shoulder swelling; edema.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this reported incident was due to right side shoulder swelling edema.The time in vivo for the reported component was 1.8 years.Final outcome did involve device being removed.This analysis is limited in scope as the devices associated with this event were not returned to djo surgical - (b)(4) for examination.If additional information regarding the event is submitted at a future date, this analysis will be re-evaluated.A review of the device history records (dhr) shows that the reported devices used in the primary surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the devices that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of use during the primary surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are in need of review.The root cause of this event is due to right side shoulder swelling edema (swelling).There were no findings during this analysis that indicate that the reported devices were 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REVERSE SHOULDER
Type of Device
STEM, HUMERAL SIZE6 RSP
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key7397367
MDR Text Key104380299
Report Number1644408-2018-00301
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888912024600
UDI-Public(01)00888912024600
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041066
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,Followup
Report Date 08/03/2018
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 Expiration Date08/28/2015
Device Model Number508-00-000
Device Catalogue Number506-00-006
Device Lot Number54033058
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2018
Initial Date FDA Received04/04/2018
Supplement Dates Manufacturer Received08/02/2018
Supplement Dates FDA Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2009
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
506-00-006, LOT 54033058; 508-32-103, LOT A1000001; 508-32-104, LOT 54050552
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient Weight95
-
-