MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION POSTERIOR STABILIZED KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM

Model Number	360-13-506
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to worn tibial insert.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as worn tibial insert.The actual length of in-vivo for the item listed is unknown as the original surgery date was notprovided or could be established.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 devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised item was not returned for examination and the item and or lot number was not provided.To adequately investigate this event, the part and or lot number are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as worn tibial insert.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Corrected data: see e.1., e.2., e.3.& g.1.Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FOUNDATION POSTERIOR STABILIZED KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10838723
• Report Number: 1644408-2020-01033
• Device Sequence Number: 19560463
• Product Code: JWH
• UDI-Device Identifier: 00888912116411
• UDI-Public: (01)00888912116411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 07/20/2021

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: 360-13-506
• Device Catalogue Number: 360-13-506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/29/2021; 03/25/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/26/2021; 07/20/2021
• 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: Required Intervention