MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; BASEPLATE, TIBIAL, STEMMED, 3D, SIZE6R NONPOROUS

Model Number	333-02-106
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the patient's knee was not stable post surgically, it was too loose.This was visible on the post surgical x-ray so they brought her back into the operating room (or) to reposition the tibia and place a thicker poly liner the next day.Her ligamentous structures were not well balanced causing it to slip, so they balanced the tissue, repositioned the tibia and placed a thicker poly liner.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient's knee was not stable post surgically, it was too loose.This was visible on the post-surgical x-ray so they brought her back into the operating room (or) to reposition the tibia and place a thicker poly liner the next day.Her ligamentous structures were not well balanced causing it to slip, so they balanced the tissue, repositioned the tibia and placed a thicker poly liner.The in-vivo length of patient service for the implant was 1 day.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 has not been made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was an ncmr# 24644 associated with the main contributor part 333-02-106, 3d knee stemmed cocrmo baseplate, size 6, which documents a nonconformance that out of 16 quantity lot 2 items were scraped due to non-compliance of tray width dimension and 5 items were rejected due to multiple pits on tray chamfer, blast on the surface.The rejected items were reworked with retouching the chamfer to remove pits, blast.All 14 items were accepted as the 5 reworked items met design requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device (s) showed no present trends or on-going issues that are in need of review.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the knee instability and loosening.There are multiple factors that may contribute to the event that are outside the control of djo surgical are inadequate soft tissue support, patient activities or trauma.The agent clearly mentioned that ligamentous structures were not well balanced causing it to slip.It seems that the event may occurred due to improper implant selection, improper surgical procedure or ligamentous laxity.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.

• Brand Name: 3DKNEE
• Common Device Name: BASEPLATE, TIBIAL, STEMMED, 3D, SIZE6R NONPOROUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6785009
• Report Number: 1644408-2017-00654
• Device Sequence Number: 19185408
• Product Code: JWH
• UDI-Device Identifier: 00888912115476
• UDI-Public: (01)00888912115476
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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 Expiration Date: 11/30/2020
• Device Model Number: 333-02-106
• Device Catalogue Number: 333-02-106
• Device Lot Number: 277B1179
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: 392-11-706, LOT 337G1061
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR