MAUDE Adverse Event Report: ENCORE MEDICAL L. P. TIBIAL INSERT KNEE; INSERT, ULTRA CONGRUENT SIZE8 19MM CM

Model Number	380-19-508
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an infection.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as an infection.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.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.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection.In addition to the part and lot numbers not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.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.

• Brand Name: TIBIAL INSERT KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE8 19MM CM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10253547
• Report Number: 1644408-2020-00619
• Device Sequence Number: 2678878
• Product Code: JWH
• UDI-Device Identifier: 00888912117388
• UDI-Public: (01)00888912117388
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 380-19-508
• Device Catalogue Number: 380-19-508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 380-15-508, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention