MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; BASEPLATE,TIBIAL, STEMMED, POROUS SIZE6 L W/NS BEADS

Model Number	311-02-106
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - found loosening implants and delamination of porous flake from the tibial component.
Additional Manufacturer Narrative
The reason for this revision surgery was loosening implants and delamination of porous flake from tibial component.Four bone screws were firmly placed.The locking screw was loose.This issue was identified during revision surgery where non-djo components were implanted.The in vivo time was approximately 5.5 years.Additional information was received, 27 dec 2018: the patient did not carry rheumatoid arthritis as previously believed, but osteoarthritis.X-rays showed, cancellous bone is being corticalized.The surgeon agrees the osteotomy at revision was tough.The physical activity of the patient is high.No non-conforming material reports were in the receivers or work orders.The devise history records evidence that all critical dimensions and specifications were met when the components were released from djo surgical.It was specifically confirmed that the baseplate porous coating met the required tensile pull specifications when tested.The incident components were returned to djo and examined.The porous surface of the femur has residual tissue and bone on the majority of the surface, indicating adequate fixation was achieved.Some gouge marks are indicative of removal by osteotome.The articulating surface has wear lines on the condyles, likely caused by the metal debris embedded in the insert.The insert shows heavy wear and delamination, which is most severe on the medial condyle.Deformation and cracking are observable on the medial edge.There is particulate embedded in the distal articulating surfaces and posterior surfaces concentrated around the medial/lateral edges.The debris is reflective and appears metallic when viewed through a stereoscope.It was reported the locking screw was loose during the revision surgery.The locking screw was retained in the explanted insert.The screw shows damage around the hex indicating that it was likely tightened during implantation.Use of a torque-limiting driver set to 45 in-lbs is recommended in the surgical technique to ensure adequate tightening.The porous surface of the baseplate demonstrates a small amount of residual tissue and bone indicating limited in-growth was achieved.Multiple bare patches of substrate are visible, confirming the delamination of porous coating.Closer examination of the exposed substrate indicates that the porous beads may not have bonded to the surface during sintering.Some areas show striations that may indicate scraping with an osteotome during explantation.The proximal surface has multiple scuff marks in a radial pattern.These marks are distributed across the entire surface with a concentration around the medial-anterior hole.The wear pattern is consistent with the location of the debris embedded in the distal surface of the insert.No other complaints have been received against these lot numbers.The complaint history for the 3d knee porous baseplate family (311/31-01/02-001/012_101/112) was reviewed.No other complaints were reported for porous coating delamination of the tibial baseplate.The root cause of this event could not be determined definitively because returned components met all design and manufacturing specification.An isolated variation in binder application could lead to the observed condition of porous delamination.Failure to use a torque limiting driver when tightening the insert retaining screw could lead to the loose screw condition.Possible factors that may have contributed to this occurrence include: patient activity level, patient obesity, a contraindication for use of this implant, patient bone density is reported as high, increased micromotion between the insert and the baseplate due to loose locking screw may have accelerated implant wear.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was loosening implants and delamination of porous flake from tibial component.Four bone screws were firmly placed.The locking screw was loose.This issue was identified during revision surgery where non-djo components were implanted.The in vivo time was approximately 5.5 years.Additional information was received, 27 dec 2018: the patient did not carry rheumatoid arthritis as previously believed, but osteoarthritis.X-rays showed, cancellous bone is being corticalized.The surgeon agrees the osteotomy at revision was tough.The physical activity of the patient is high.No non-conforming material reports were in the receivers or work orders.The devise history records evidence that all critical dimensions and specifications were met when the components were released from djo surgical.It was specifically confirmed that the baseplate porous coating met the required tensile pull specifications when tested.The incident components were returned to djo and examined.The porous surface of the femur has residual tissue and bone on the majority of the surface, indicating adequate fixation was achieved.Some gouge marks are indicative of removal by osteotome.The articulating surface has wear lines on the condyles, likely caused by the metal debris embedded in the insert.The insert shows heavy wear and delamination, which is most severe on the medial condyle.Deformation and cracking are observable on the medial edge.There is particulate embedded in the distal articulating surfaces and posterior surfaces concentrated around the medial/lateral edges.The debris is reflective and appears metallic when viewed through a stereoscope.It was reported the locking screw was loose during the revision surgery.The locking screw was retained in the explanted insert.The screw shows damage around the hex indicating that it was likely tightened during implantation.Use of a torque-limiting driver set to 45 in-lbs is recommended in the surgical technique to ensure adequate tightening.The porous surface of the baseplate demonstrates a small amount of residual tissue and bone indicating limited in-growth was achieved.Multiple bare patches of substrate are visible, confirming the delamination of porous coating.Closer examination of the exposed substrate suggests the possibility of insufficient contact between porous beads and the surface during sintering.The remaining coating appears to be well bonded and there is no definitive explanation for the observed condition.Some areas show striations that may indicate scraping with an osteotome during explanation the proximal surface has multiple scuff marks in a radial pattern.These marks are distributed across the entire surface with a concentration around the medial-anterior hole.The wear pattern is consistent with the location of the debris embedded in the distal surface of the insert.No other complaints have been received against these lot numbers.The complaint history for the 3d knee porous baseplate family (b)(4) was reviewed.No other complaints were reported for porous coating delamination of the tibial baseplate.The root cause of this event could not be determined definitively because returned components met all design and manufacturing specification.An isolated variation in binder application could lead to the observed condition of porous delamination.Failure to use a torque limiting driver when tightening the insert retaining screw could lead to the loose screw condition.Possible factors that may have contributed to this occurrence include: patient activity level, patient obesity, a contraindication for use of this implant, patient bone density is reported as high, increased micromotion between the insert and the baseplate due to loose locking screw may have accelerated implant wear.

• Brand Name: FOUNDATION KNEE
• Common Device Name: BASEPLATE,TIBIAL, STEMMED, POROUS SIZE6 L W/NS BEADS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8187573
• Report Number: 1644408-2018-01161
• Device Sequence Number: 2111835
• Product Code: JWH
• UDI-Device Identifier: 00888912113694
• UDI-Public: (01)00888912113694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2019

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: 08/31/2016
• Device Model Number: 311-02-106
• Device Catalogue Number: 311-02-106
• Device Lot Number: 108B1005
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 03/06/2019; 05/06/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 03/08/2019; 05/14/2019
• 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: 010-55-015, LOT 003A1034; 010-55-015, LOT 003A1034; 010-55-015, LOT 003A1034; 010-55-015, LOT 003A1035; 010-55-020, LOT 005A1050; 010-55-020, LOT 005A1050; 010-55-220, LOT 005A1050; 010-55-220, LOT 005A1050; 236-01-107, LOT 54040093; 236-01-107, LOT 54040093; 311-02-106, LOT 108B1005; 391-09-607, LOT 54039163; 391-09-607, LOT 54039163
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 95