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

Model Number	508-00-000
Health Effect - Clinical Codes	Edema (1820); Swelling (2091)
Date of Event	02/08/2012
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Reported incident - due to the patient having right shoulder swelling; edema.
Additional 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
• Common Device Name: STEM, HUMERAL SIZE6 RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7397367
• Report Number: 1644408-2018-00301
• Device Sequence Number: 18849374
• Product Code: PHX
• UDI-Device Identifier: 00888912024600
• UDI-Public: (01)00888912024600
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-00-006, LOT 54033058; 508-32-103, LOT A1000001; 508-32-104, LOT 54050552
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95