MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE TIBIAL DOWNSIZE NON-POROUS; TIBIA, STEMMED, POROUS SIZE10 R 3D

Catalog Number	335-02-110
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to patient falling on their knee.They presented at the surgeon's clinic with knee pain.The computerized tomography (ct) scan "lit up" around the tibia component according to the surgeon.The tibial component was evaluated and determined to be loose.The surgeon removed the loose tibia along with the poly spacer and 4 tibial screws.He cemented in a new tibia baseplate and put in a new poly liner.
Additional Manufacturer Narrative
The reason for this revision surgery was knee pain and the tibial component was loose.The previous surgery and the revision detailed in this investigation occurred over 2 years apart.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.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 were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date 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.The root cause of this complaint was a revision surgery due to knee pain and a loose tibial component.The root cause for the pain and device loosening was reported as a fall.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.

• Brand Name: 3D KNEE TIBIAL DOWNSIZE NON-POROUS
• Common Device Name: TIBIA, STEMMED, POROUS SIZE10 R 3D
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6437508
• Report Number: 1644408-2017-00176
• Device Sequence Number: 780136
• Product Code: JWH
• UDI-Device Identifier: 00888912115742
• UDI-Public: (01)00888912115742
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 04/30/2020
• Device Catalogue Number: 335-02-110
• Device Lot Number: 308B1021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/03/2017
• 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: 010-55-020, LOT 005A1113; 010-55-025, LOT 006A1145; 392-13-710, LOT 59605106
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR