MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

Model Number	508-00-436
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to glenosphere disassociation.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to a glenosphere disassociation.The previous surgery and the revision detailed in this investigation occurred 2.7 months apart.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 a significant adverse event to the patient.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 not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.There was a non-conforming material report (ncmr) (b)(4)associated with part 508-36-101, rsp 36mm neutral glenoid head with retaining screw which documents a nonconformance that (b)(4) items were rejected due to dings in the chamfer at the bottom of the female taper feature.All (b)(4) items were accepted with the justification that this surface is not a part of the taper itself and does not mate with any implants or instruments.Also the marketing approval had accepted with dings on this chamfer surface.All items in this lot were met the fit, design and functional requirements.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to glenosphere disassociation.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: patient activities, inadequate soft tissue support, potential impingement, improper implant engagement, excessive range of motion, patient bone deterioration or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.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: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7080610
• Report Number: 1644408-2017-01071
• Device Sequence Number: 19057662
• Product Code: KWS
• UDI-Device Identifier: 00888912024686
• UDI-Public: (01)00888912024686
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 03/02/2023
• Device Model Number: 508-00-436
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C2182
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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: 508-36-101, LOT 869C2182
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR