MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE SYSTEM; FEMUR, NONPOROUS, SIZE8, LT

Model Number	201-01-108
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient presented with pain due to femoral component loosening.
Additional Manufacturer Narrative
Corrected data: see brand name; common device name; concomitant medical products.Manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred over 14 years and 10 months apart.The healthcare professional indicated there was no significant adverse event.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The part associated with this investigation was not returned to djo surgical for review.A review of the implant device history records (dhr) shows that the reported component 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 and its applicable concomitant device were within their respective expiration dates at the time of use during the previous surgery.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 loosening.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the event.It seems that the event may possibly occurred due to loose joint from degenerative tissues, excessive range of motion, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - patient presented with pain due to femoral component loosening.
Additional Manufacturer Narrative
Corrected data.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as loosening.The previous surgery and the revision detailed in this investigation occurred over 14 years and 10 months apart.The healthcare professional indicated there was a 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the event.The device and its applicable concomitant device were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported devices 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 loosening.There were no findings during this investigation that indicate the reported devices were the source or had a direct connection with the patient's event.Agent has clearly mentioned that, "patient was presented with pain due to femoral component loosening".It seems that the event may possibly occurred due to loose joint from degenerative tissues, excessive range of motion, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE SYSTEM
• Common Device Name: FEMUR, NONPOROUS, SIZE8, LT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• MDR Report Key: 8928203
• Report Number: 1644408-2019-00787
• Device Sequence Number: 16748567
• Product Code: JWH
• UDI-Device Identifier: 00888912109215
• UDI-Public: (01)00888912109215
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/30/2019

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: 08/31/2010
• Device Model Number: 201-01-108
• Device Catalogue Number: 201-01-108
• Device Lot Number: 207302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019; 07/26/2019; 12/03/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/08/2019; 12/26/2019; 01/02/2020
• 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: 201-01-108, LOT 207302; 323-01-108 LOT 219232; 323-01-108, LOT 219232
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR