MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP HUM SOCKET INSERT, 32MM, +4MM, STANDARD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	508-00-432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/28/2023
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 instabiity.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01728; 508-00-432, s814 - stability, poor joint, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: RSP HUM SOCKET INSERT, 32MM, +4MM, STANDARD
• 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: 17822428
• Report Number: 1644408-2023-01316
• Device Sequence Number: 20384874
• Product Code: KWS
• UDI-Device Identifier: 00888912024679
• UDI-Public: 00888912024679
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2015
• Device Catalogue Number: 508-00-432
• Device Lot Number: 918F1006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2010
• 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: 831C1060.; 506-03-114 LOT: 831C1060.; 506-03-114 LOT: UNKNOWN.; 506-03-130 LOT: 835C1049.; 506-03-130 LOT: 835C1050.; 506-03-130 LOT: UNKNOWN.; 508-32-101 LOT: 862C1112.; 508-32-101 LOT: UNKNOWN.; 508-32-104 LOT: 866C1241.; 508-32-104 LOT: UNKNOWN.; 510-00-008 LOT: 979F1029.; 510-00-008 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female