MAUDE Adverse Event Report: Encore Medical L.P DJO SURGUCAL; EMPOWR CR KNEETM TIBIAL INSERT, RIGHT, SIZE 6, 11MM

Catalog Number	345-11-706
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to unknown revision reason / poly swap.
Additional Manufacturer Narrative
The agent reported, revision surgery: "poly swap.Size 6 11mm poly was removed.Size 6, 16mm was put in" the actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.Item number: 345-11-706 item description: empowr cr kneetm tibial insert, right, size 6, 11mm lot number: unknown part revision: na product type: knee manufacture date: unknown expiration date: unknown.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item(s) was not returned for examination and the item and or lot number(s) was not provided.To adequately investigate this event, the part and lot number(s) are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item(s) showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: DJO SURGUCAL
• Common Device Name: EMPOWR CR KNEETM TIBIAL INSERT, RIGHT, SIZE 6, 11MM
• 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: 50293553
• Report Number: 1644408-2026-01693
• Device Sequence Number: 13444995
• Product Code: JWH
• UDI-Device Identifier: 00190446215943
• UDI-Public: 00190446215943
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 08/18/2026

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: 345-11-706
• Device Lot Number: Unknown
• 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: 04/15/2022
• Initial Report FDA Received Date: 08/18/2026
• 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: 71 YR
• Patient Sex: Female