MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE4R

Model Number	324-01-104
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to fracture.The previous surgery and the revision detailed in this investigation occurred over 1 year 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 was a nonconformance associated with the part # 324-01-104, baseplate stemmed non porous tibial cocr size 4r, that out of 16 quantities lot, 1 part was rejected and scrapped due to cracks in the face of part & too thin walls.All other items in the lot were met with design and manufacturing 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 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 fracture.Agent has clearly mentioned that, "trauma related fractured tibia.Removed everything except for patella", it seems that the event may have possibly occurred due to lack of post-operative care, patient noncompliance with medical instructions, poor bone density, patient bone deterioration, degenerative bone disease, patient activities or trauma.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.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.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to trauma related fractured tibia; surgeon removed everything except for the patella.

• Brand Name: FOUNDATION KNEE
• Common Device Name: BASEPLATE, STEMMED, NON POROUS TIBIAL COCR SIZE4R
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8755906
• Report Number: 1644408-2019-00604
• Device Sequence Number: 2566355
• Product Code: JWH
• UDI-Device Identifier: 00888912115179
• UDI-Public: (01)00888912115179
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 10/26/2023
• Device Model Number: 324-01-104
• Device Catalogue Number: 324-01-104
• Device Lot Number: 233B1218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/02/2019
• 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: 70 YR