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

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.

• 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 Key: 7397367
• MDR Text Key: 104380299
• Report Number: 1644408-2018-00301
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024600
• UDI-Public: (01)00888912024600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041066
• Number of Events Reported: 1
• 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

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 508-00-000
• Device Catalogue Number: 506-00-006
• Device Lot Number: 54033058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 506-00-006, LOT 54033058; 508-32-103, LOT A1000001; 508-32-104, LOT 54050552
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95