MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; SLIDJNG CORE, UHMPWE,8MM

Catalog Number	400-142F
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "ankle was unbalanced and needed to be repaired.Slight wear to old poly." due to the original poly lot number remaining unknown, simulated use testing cannot be conducted utilizing similar parts to simulate the event.Additionally, the poly component was implanted for an unknown amount of time, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.There were 32 similar complaints identified for star poly swaps with no reported damage beyond normal wear.Previous complaints were investigated and documented by stryker prior to february 2023 and do not aid in investigation for this complaint.The reporter stated the "ankle was unbalanced and needed to be repaired.Slight wear to old poly".As the reporter noted slight wear to the poly, the device is not expected to be the cause of the imbalance but cannot be confirmed due to the component not being returned.Dhr review was not conducted due to the complaint part not being returned and the lot numbers remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available.The poly was not returned, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Based on the limited information, and the poly not being returned, the root cause shall remain as unknown.The following information remains unknown: date implanted, patient gender, patient age, patient weight, patient date of birth, patient bone quality, patient noncompliance, patient bo-morbidities, part number, lot murmer, inventory status.Information not provided is not available to the reporter.Thus, good faith effort is achieved.The overall risk is high with a risk index of 3.Severity level of 4 (significant) is appropriate as there could be permanent functional impairment of body function and the failure may occur with or without warning.It is to be noted that no adverse events were reported resulting from the swapped poly.It was determined that 820 tibial polymer components (pn: 400-14x) were sold during march 2022 and march 2023.With 32 reported events, the occurrence rate is (b)(4).Thus, an occurrence level of 5 (frequenuhigh)i is appropriate.Per rf-str-0001 revision 1 risk benefit analysis for u23.2, "every endoprosthe: is has a limited lifespan.With state-of-the-art techniques, there is no potential for further mitigation of the risks from a clinical point of view".Therefore, the risk shall remain appropriate.Though the root cause is unknown, it is not expected to be attributed to the supplier.
Event or Problem Description
Revision surgery - due to instability.

• Brand Name: DJO SURGICAL
• Common Device Name: SLIDJNG CORE, UHMPWE,8MM
• 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: 24671381
• Report Number: 1644408-2026-00600
• Device Sequence Number: 21383463
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/23/2026

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: 400-142F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/23/2026
• 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 Sex: Unknown