MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION KNEE; INSERT, ULTRA CONGRUENT SIZE4 15MM CM

Model Number	380-15-504
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient's knee being too tight; the surgeon had to replace and exchange the original insert.
Additional Manufacturer Narrative
The reason for this revision surgery was tightness in knee.The previous surgery and the revision detailed in this investigation occurred over 3 years and 1 month 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 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 was within its expiration date 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 the tightness in knee.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient activities, inadequate soft tissue support, patient bone deterioration, low bone density, excessive load or trauma.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: FOUNDATION KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE4 15MM CM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6647924
• Report Number: 1644408-2017-00469
• Device Sequence Number: 19074148
• Product Code: JWH
• UDI-Device Identifier: 00888912117289
• UDI-Public: (01)00888912117289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2017

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: 06/30/2018
• Device Model Number: 380-15-504
• Device Catalogue Number: 380-15-504
• Device Lot Number: 59603515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/29/2017
• 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: 62 YR