MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 6RT 11MM

Model Number	392-11-706
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as polywear or instability.The actual length of in-vivo for the item 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 device was disposed of at the hospital and not made available to djo surgical for examination.The revised item was not returned for examination and the item's lot numbers was not provided.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to polywear or instability.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.
Event or Problem Description
Revision surgery - obese patient complained of knee instability.Surgeon thought implant might be loose.Revision surgery proved implants stable, well fixed but poly insert had wear.Poly extracted and replaced with new poly insert.

• Brand Name: 3D KNEE
• Common Device Name: INSERT, 3D EX SZ 6RT 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10206417
• Report Number: 1644408-2020-00511
• Device Sequence Number: 2108192
• Product Code: OIY
• UDI-Device Identifier: 00888912120531
• UDI-Public: (01)00888912120531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• 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
• Report Date (Section B): 06/29/2020

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: 392-11-706
• Device Catalogue Number: 392-11-706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/29/2020
• 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: Required Intervention
• Patient Age: 62 YR