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

Model Number 508-36-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 02/08/2023

Event Type  Injury  

Event Description

Revision surgery pain impingement.

Manufacturer Narrative

The agent reported "(patient was a previous fracture surgery whose greater tuberosity migrated superiorly causing an impingement.This bone was removed and a glenosphere and poly swap was also done)".The previous surgery and the surgery detailed in this event occurred 7 months and 1 week apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event 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 reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.A review of the device history records (dhr) show 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 (ncmr) associated with the products 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 the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to tuberosity migrated causing an impingement.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.

• Brand Name: REVERSE PROSTHESIS SHOULDER SYSTEM
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 16406027
• MDR Text Key: 309886219
• Report Number: 1644408-2023-00227
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024761
• UDI-Public: 00888912024761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2023

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 Model Number: 508-36-101
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C3509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 509-00-036 , LOT 378P1318
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male