MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Catalog Number	243-01-108
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - 45 minute delay in surgery.
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
The agent reported "opened the box for a pressfit femur sz 8 left, and it had a pressfit left tibia minus 8 in the box (353-03-108 / lot 213w1051).The tibia that was in the femur box was the size tibia we wanted to use, so that was used, and i had to drive back to my office to get a spare femur which resulted in a 45 min delay during the surgery.".This event occurred during surgery, away from the patient.There was forty-five (45) minute delay in surgery, but the surgery was completed as intended.The implant was inspected prior to use and found to be unacceptable.The agent was present when this event occurred and the was able to provide another suitable device.The reported device was not returned to surgical for evaluation, the packaging was returned.Work order (b)(4) for 353-03-108, empowr tibia, 8l, lot 213w1051, began with (b)(4) parts on january 16, 2023.On february 21, 2023, (b)(4) part was scrapped and noted on the traveler, leaving (b)(4).Parts to continue through the manufacturing process.On april 4, 2023, at the label generation operation the operator wrote (b)(4) parts, which was later corrected to (b)(4) parts.On april 4, 2023, 21 labels were printed; an extra label is printed to affix to the dhr as a record.The operator likely created (b)(4) instead of (b)(4) labels due to a miscount in the physical part quantity.The additional label should have been destroyed.The work order was closed on april 13, 2023 with (b)(4) parts as the final count.Work order (b)(4) for 243-01-108, empowr 3d femur, 8l, lot 277w1114, began with (b)(4) parts on may 3, 2023.On may 8, 2023, the label generation operation, (b)(4) labels were printed; an extra label is printed to affix to the dhr as a record.There is no record of an additional label being generated after the label generation operation.The work order was closed on may 17, 2023 with (b)(4) parts as the final count.Reference (b)(4) for further details.The complaint history was reviewed and there were no other complaints reported for the reported failure.Root cause: during the final packaging of 243-01-108, empowr 3d femur, 8l, lot 277w1114, it is likely the 353-03-108, empowr tibia, 8l, lot 213w1051, was placed on the same workspace resulting in line clearance not being maintained and the parts being comingled.

• Brand Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18026732
• Report Number: 1644408-2023-01537
• Device Sequence Number: 15407657
• Product Code: MBH
• UDI-Device Identifier: 00190446231295
• UDI-Public: 00190446231295
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/14/2023

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: 243-01-108
• Device Lot Number: 277W1114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/28/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: 353-03-108 LOT: 213W1051.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female