MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; BASEPLATE, TIBIAL, STEMMED, 3D, SIZE10L NONPOROUS

Model Number	333-01-110
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as loosening.The reported previous surgery and the surgery detailed in this event occurred 9.3 years apart.The baseplate, and as indicated by the attached revision dticket, there may have been multiple items removed.Without the previous dticket/invoice, the items cannot be verified.The healthcare professional indicated there was an significant adverse event to the patient.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 revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, the lot number is necessary.If this information is submitted at a future date, this investigation will be re-evaluated.There was no other information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.
Event or Problem Description
Revision surgery - loose tibia due to screw placement could not located the previous dticket.

• Brand Name: 3D KNEE
• Common Device Name: BASEPLATE, TIBIAL, STEMMED, 3D, SIZE10L NONPOROUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9779834
• Report Number: 1644408-2020-00147
• Device Sequence Number: 19011198
• Product Code: JWH
• UDI-Device Identifier: 00888912115438
• UDI-Public: (01)00888912115438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 333-01-110
• Device Catalogue Number: 333-01-110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 111