MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; LINEAR, LATERAL, REDUCED NECK, SZ 5, W/P2 COATING

Catalog Number	425-99-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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
Primary surgery - empower headball wouldn't fit on tight with linear stem causing a 20 minute delay in surgery.
Additional Manufacturer Narrative
Empower headball wouldn't fit on tight with linear stem, causing the dr to use zimmer biomet for a different stem.Essentially there's something wrong with the stem.The reported instrument with lot 570g1964 was returned to enovis surgical for evaluation.The empower ball was not returned for evaluation.The instrument was tested by an enovis attendee and was found to be in tolerance.A review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Inspections was performed to check the tolerance, the inspection results show the instrument is in tolerance.On (b)(6) 2025 the instrument went through parts verification.Complaint database review showed no previous complaints that allege this same issue.There are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: DJO SURGICAL
• Common Device Name: LINEAR, LATERAL, REDUCED NECK, SZ 5, 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 ; 5128346313
• MDR Report Key: 21087344
• Report Number: 1644408-2024-02059
• Device Sequence Number: 15178089
• Product Code: LPH
• UDI-Device Identifier: 00888912078917
• UDI-Public: 00888912078917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 02/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 425-99-005
• Device Lot Number: 570G1964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/24/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown