MAUDE Adverse Event Report: Encore Medical L.P DJO SURGICAL; HEAD, FEMORAL, CERAMYS, 36MM, S, -4MM

Catalog Number	402-03-361
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
Date of Event	08/15/2026
Type of Reportable Event	Serious Injury

• Brand Name: DJO SURGICAL
• Common Device Name: HEAD, FEMORAL, CERAMYS, 36MM, S, -4MM
• 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: 50681116
• Report Number: 1644408-2026-01684
• Device Sequence Number: 5315690
• Product Code: LZO
• UDI-Device Identifier: 00190446843597
• UDI-Public: 00190446843597
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K241483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/08/2026

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: 402-03-361
• Device Lot Number: 6118444
• 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: 08/15/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male