MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; SOCKET, SHELL NEUTRAL RSP

Catalog Number	508-00-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the modular shell having disassociated from the stem.The problem was that the original surgeon did not impact the shell hard enough to the stem to lock it in.The surgeon replaced the shell, liner, and glenosphere and the outcome was successful.
Additional Manufacturer Narrative
The reason for this revision surgery was the modular shell disassociated from the stem.The date of the original surgery was not reported or could be established therefore the length of in-vivo service is undetermined.The complaint reported no issues of any other patient injuries, activities, accidents or manufacturing contraindications that may have been contributory to this surgery.No reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.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 device history record (dhr) was not conducted since a lot number was not provided or established.The complaint investigation history was reviewed and no trends or on-going issues were deemed as present or in need of review.No further action is deemed necessary at this time.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.This event is deemed as non-product related.The root cause for this event was reported as the socket shell was not impacted properly for optimum performance.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Common Device Name: SOCKET, SHELL NEUTRAL RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6450651
• Report Number: 1644408-2017-00201
• Device Sequence Number: 19006195
• Product Code: KWS
• UDI-Device Identifier: 00888912024600
• UDI-Public: (01)00888912024600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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 Catalogue Number: 508-00-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/22/2017
• 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: 506-03-122; 508-00-032; 508-32-101
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR