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

Model Number 392-11-706

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 06/01/2020

Event Type  Injury  

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 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
• Type of Device: INSERT, 3D EX SZ 6RT 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx
• MDR Report Key: 10206417
• MDR Text Key: 196991834
• Report Number: 1644408-2020-00511
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120531
• UDI-Public: (01)00888912120531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 392-11-706
• Device Catalogue Number: 392-11-706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR