MAUDE Adverse Event Report: ENCORE MEDICAL L.P FOUNDATION KNEE; INSERT, ULTRA CONGRUENT SIZE10 11MM CM

Model Number	380-11-510
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - due to inlay fracture (pin) of knee prosthesis.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as inlay failure/ broken pin.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.Initial or prolonged hospitalization was required.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.The lot number was not reported, therefore; this item could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.There are few complaints associated with the main component were 2 pain total, 1 infection and 2 stability poor joint total.The definitive root cause, of the inlay failure/ broken pin, cannot be determined without the component.The findings did not lead to a firm conclusion since the item/lot number was not reported at the time of this investigation.There was no information reported that evidences a material, design, or manufacturing problem with the product.Possible causes include but limited to: tilt in medial/lateral direction, change in the alignment of the extremity, crack formation at cement-implant interface, third-body wear, trauma, compromised proximal tibial bone quality, improper stress loads, poor cementing techniques, and high rotational constraint.It cannot be determined if one or any of these causes led to failure of the component.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE10 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 12218180
• Report Number: 1644408-2021-00741
• Device Sequence Number: 14564898
• Product Code: JWH
• UDI-Device Identifier: 00888912117166
• UDI-Public: (01)00888912117166
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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 Model Number: 380-11-510
• Device Catalogue Number: 380-11-510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention