MAUDE Adverse Event Report: Encore Medical L.P. DJO SURGICAL; RSP BASEPLATE, 30MM, W/P2 COATING

Catalog Number	508-32-204
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Incompetent Cervix (1927)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to patient had failed/ broken center screw on baseplate.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2024-02149; 508-32-204, s801 - device cracked/broke, s802 - device failed, 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: RSP BASEPLATE, 30MM, W/P2 COATING
• 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: stacey bonnell ; 9800 metric blvd.; austin, TX 78758
• MDR Report Key: 50311012
• Report Number: 1644408-2026-01556
• Device Sequence Number: 8770694
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: 00888912144391
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 08/18/2026

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: 508-32-204
• Device Lot Number: 769P2911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: 506-03-118 Lot: 832C2202; 506-03-126 Lot: 834C2225; 508-32-103 Lot: 864C6224; 509-02-032 Lot: 951W2176A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female