MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; 44MM RSP GLEN HD +8MM

Catalog Number	508-44-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dislocation.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
D4 expiration date.Complaint has been evaluated and is similar to: 1644408-2021-00891; 508-44-101, s803 - dislocation, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct d4 lot number to unknown and expiration date to unknown, h4 device manufacturer date to unknown and add h10 related report number.

• Brand Name: DJO SURGICAL
• Common Device Name: 44MM RSP GLEN HD +8MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20186456
• Report Number: 1644408-2024-01359
• Device Sequence Number: 8032059
• Product Code: KWS
• UDI-Device Identifier: 00888912024785
• UDI-Public: 00888912024785
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 12/12/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 11/19/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/26/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: 509-01-044 LOT: 384P1016A.; 509-01-044 LOT: UNKNOWN.; 530-14-108 LOT: 415T1447.; 530-14-108 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male