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

Model Number	508-00-000
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/07/2013
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
Revision surgery - due to the patient having a right side deep infection.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this reported incident was due to right side deep infection.This event did involve devices being removed.Outcome-devices removed 1.6 years from date of shoulder replacement.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.This investigation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the infection.A review of the implant device history records (dhr), shows that the reported components 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 components that may have contributed to the infection.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous 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 deep infection , op joint/op wound.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 infection.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: RSP 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: 7397373
• Report Number: 1644408-2018-00300
• Device Sequence Number: 1216301
• 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: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: 04/28/2017
• Device Model Number: 508-00-000
• Device Catalogue Number: 506-00-006
• Device Lot Number: 810C1033
• 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: 07/25/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 07/26/2018
• 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 810C1033; 508-00-000, LOT 848C1164; 508-32-103, LOT 864C1089; 508-32-103, LOT 864C1089; 508-32-104, LOT 866C1163; 508-32-104, LOT 866C1163
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 61