MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 44MM RSP GLEN HD +8MM,; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	508-44-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to dissociation.
Additional Manufacturer Narrative
See d4 expiration date, d9, h2,h3, h4 and h11.Complaint has been evaluated and is similar to previous report number 1644408-2018-00026; 508-44-101, s817 - dissociation, revision surgery.Note: the items associated with this investigation were returned to djo surgical - austin for examination.An inspection, of the head and baseplate that would be more prone to a disassociation, could not be attempted due to excessive damage.The damage was most likely due to being extracted.The size verification inspection that could be verified was found to be acceptable.Taper angle and taper diameter of head and baseplate are subject to 100% inspection.The dhrs evidence that all critical dimensions and specifications were met when all components were released from djo surgical, see attached work orders and purchase orders.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: 44MM RSP GLEN HD +8MM,
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18897131
• Report Number: 1644408-2024-00292
• Device Sequence Number: 6130609
• Product Code: KWS
• UDI-Device Identifier: 00888912024785
• UDI-Public: 00888912024785
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/12/2024

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: 508-44-101
• Device Lot Number: 877C1188
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: 831C2495; 506-03-118 LOT: 832C1947; 506-03-122 LOT: 831C2495; 508-32-204 LOT: 769P2996; 509-00-044 LOT: 380P1044
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male