MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM, NEUTRAL

Catalog Number	508-40-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to patient presented to dr with pain, loss of motion and strength, following a revision reverse total shoulder.Xrays confirmed a disassociation of the glenosphere from the baseplate.Patient and dr agreed a revision was merited.The procedure confirmed the disassociation and a loose humeral stem.Everything inventoried above was removed from the patient and replaced by implants on revision.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to: 1644408-2024-00843; 508-36-101, s817 - dissociation, s810 - device loosening, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 40MM, NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 20018530
• Report Number: 1644408-2024-01272
• Device Sequence Number: 7448861
• Product Code: PHX
• UDI-Device Identifier: 00888912144490
• UDI-Public: 00888912144490
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 508-40-101
• Device Lot Number: 875C1448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-114 LOT: 831C2550; 506-03-122 LOT: 833C2064; 506-03-130 LOT: 835C2241; 506-03-130 LOT: 835C2245; 509-00-040 LOT: 379P1160; 510-08-000 LOT: 142G1579; 530-10-108 LOT: 409T1950
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male