MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION POSTERIOR STABILIZED (PS) KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE4 15MM CM

Model Number	360-15-504
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the original poly breaking loose from the screw.The poly popped off the baseplate, but the screw is stil intact within the tibial baseplate.
Additional Manufacturer Narrative
The reason for this revision surgery was the original poly broke loose from the screw.The in-vivo length of patient service for the implant was 38 days.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.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.Visual inspection of the explanted part reveals a damaged uhmwpe tibial insert with the retention screw in place within the body of the insert.The complaint report indicates the screw stayed in the baseplate until the revision surgery.No explanation is given for how the screw came to be in the returned insert but it may be assumed that it was reassembled prior to return.The explanted screw is firmly retained within the insert and the area around the screw hole in the distal surface exhibits some damage, indicating the possibility that the screw was pulled through the hole due to the dissociation.The distal face of the insert shows extensive damage including deep grooves that indicate contact with the anterior edge geometry of the baseplate.In addition, multiple circular grooves demonstrate contact with the screw while it was retained in the baseplate.The cruciate notch exhibits considerable damage along the distal edge, likely due to contact with the screw as well.The post shows damage on the uppermost corners indicating that the insert rotated beyond its usual range of motion and made contact with the femur in these areas.The posterior tabs are designed to slide under the edge of the baseplate rail.However, those on the returned insert exhibit bending damage that would be consistent with impaction of the insert while the tabs were above the edge of the baseplate rail.In addition, the anterior locking tabs are in near-perfect condition, pointing to the possibility that the anterior tabs were never engaged with the baseplate.In this condition, the retention screw would have been only partially engaged.The physical condition of the explanted component indicates that the insert was not implanted properly, leading to dissociation.A review of the device history records (dhr) for the foundation ps tibial insert revealed no non-conforming material reports (ncmr's) associated with the product.The incident ps tibial insert was one of five pieces in the lot released from manufacture on or about (b)(4) 2013, and having an expiration date of (b)(4) 2018.The dhr evidences that all critical dimensions and specifications were met when the product was released from djo surgical.Review of complaint history shows that this is the first complaint against this part/lot number.In the 360 part family there is a record of 4 other occurrences of dissociation between 2010 and 2014.There was no information reported that evidences a material, design, or manufacturing problem with the product.The root cause is likely related failure to properly engage the tibial insert with the baseplate leading to dissociation.This may be to improper surgical technique or debris on the baseplate.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION POSTERIOR STABILIZED (PS) KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE4 15MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6343217
• Report Number: 1644408-2017-00092
• Device Sequence Number: 1042306
• Product Code: JWH
• UDI-Device Identifier: 00888912116473
• UDI-Public: (01)00888912116473
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 08/31/2018
• Device Model Number: 360-15-504
• Device Catalogue Number: 360-15-504
• Device Lot Number: 59603739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: Other; Required Intervention
• Patient Age: 67 YR