MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40

Catalog Number	952-28-40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - the 40e dual mobility bearing with the lot number 2224a1124a was actually a 42f dual mobility bearing.
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
See d4 expiration date, h4, h6 and h11.The agent reported "the implant inside this package was a size f and not a size e as it says on the package.Female, 45".This event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.There was a 15-minute delay in surgery, but the surgery was completed as intended.There was another suitable device available.The device was inspected prior to use and found acceptable.Rma examination: the reported device(s) was returned to surgical for evaluation.It is confirmed a 952-28-42f was in the packaging of a 952-28-40e, reference (b)(4).Twenty (20) pieces of 952-28-40e, empowr acetabular, dual mobility, poly bearing, id28, od40, were processed on work order (b)(4).These parts went through final pack on 12/18/2024.Twenty (20) pieces of 952-28-42f, empowr acetabular, dual mobility, poly bearing, id28, od42, were processed on work order (b)(4).These parts went through final pack on 12/18/2024.Upon further review, both work orders were processed by the same operator at part final pack on 12/18/24.Due to the foam that is present within the tray, the device cannot be verified once the tray has been sealed.On march 4, 2025 encore medical, l.P.Dba djo surgical was notified that a 952-28-42f (lot 2225a1124), empowr acetabular, dual mobility, poly bearing, id28, od42, was found within the packaging of a 952-28-40e (lot 2224a1124a), empowr acetabular, dual mobility, poly bearing, id28, od40.Investigation summary: twenty (20) pieces of 952-28-40e, empowr acetabular, dual mobility, poly bearing, id28, od40, lot 2224a1124a, were processed on work order (b)(4).These parts went through automated part verification (vei) through final pack: quality check on december 18, 2024.Twenty (20) pieces of 952-28-42f, empowr acetabular, dual mobility, poly bearing, id28, od42, lot 2225a1124, were processed on work order (b)(4).These parts went through automated part verification (vei) through final pack: quality check on december 18, 2024.Both work orders were confirmed to have gone through the vei and shows passing results.The vei does a size verification to ensure the correct part is present prior to tray sealing.The video records within the inner pack were reviewed and showed the work orders were processed at separate times and there that was no evidence of breakage in line clearance.Both work orders contained evidence of post sterilization scanning being completed.The post sterilization scanning cross references the lot number with the barcode label under the tray, work order, and outer packaging label for each tray.Therefore, it can be concluded that the swap did not occur during the post sterilization operation.The reported device was returned to surgical for evaluation.The tray barcode label show 952-28-42f with a barcode 2225a1124-1221; the physical part that was sealed with 952-2-842f.The correct was sealed into the tray.The tyvek lid label shows 952-28-40e, this label is placed onto the tray after sterilization and post-sterilization scanning.The tyvek label matches the outer boxing labels.Root cause of the problem:it is likely the swap occurred during outer boxing.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40
• 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: 21896565
• Report Number: 1644408-2025-00448
• Device Sequence Number: 11623721
• Product Code: LPH
• UDI-Device Identifier: 00190446673194
• UDI-Public: 00190446673194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/29/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 952-28-40E
• Device Lot Number: 2224A1124A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female