MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; STEM, HUMERAL SIZE8 RSP

Model Number 508-00-032

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Dislocation (2374)

Event Date 08/06/2010

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 right shoulder dislocation.

Manufacturer Narrative

Manufacturer narrative: the reason for this reported incident was due to right side - shoulder dislocation.This event did not involve the devices being removed.Outcome-resolved 53 days from date of shoulder replacement.This analysis is limited in scope as the devices associated with this event remain in the patient, therefore will not be returned to djo surgical - (b)(6) 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 dislocation.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: RSP SHOULDER
• Type of Device: STEM, HUMERAL SIZE8 RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7397370
• MDR Text Key: 104403022
• Report Number: 1644408-2018-00298
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024648
• UDI-Public: (01)00888912024648
• Combination Product (y/n): N
• PMA/PMN Number: K041066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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 Date: 06/28/2016
• Device Model Number: 508-00-032
• Device Catalogue Number: 506-00-008
• Device Lot Number: 814C1001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-00-008, LOT 814C1001; 508-00-032, LOT A1000014; 508-32-101, LOT 862C1011; 508-32-101, LOT 862C1011; 508-32-104, LOT 866C1011; 508-32-104, LOT 866C1011
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 77