MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PS KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE10 9MM CM

Model Number	360-09-510
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to cracking inside the knee, instability, broken cam of the posterior stabilized inlay.
Additional Manufacturer Narrative
The reason for this revision surgery was due to a broken cam.The previous surgery and the revision detailed in this investigation occurred 6.7 years apart.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.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.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 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.A review of the implant device history records (dhr), shows non-conforming material report (ncmr) #(b)(4) for (part# 213-01-010) receiver lot purchase order (b)(4), 11 parts rejected for e-e profile.Disposition 11 parts rework, steps added to work order (wo) #(b)(4) operation #15/415, 11 parts acceptable after rework.There were no other non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration dates at the time of use during the previous surgery.The ultra-high molecular-weight-polyethylene (uhmw-pe) raw material was identified as ticona 1050, material lot 239541 and does not contain stearates.The poly was extruded and annealed to a 2.50"x3.75" rod and shown on the certificate of conformance to have a yield strength of 3234psi, an ultimate strength of 7700 psi, elongation to break of 421%, izod impact strength of 49.0 ft-lb/in and was certified to meet material specification #2 prior to shipment.As mentioned in previous investigation: (test os9310-01, stability characteristics of the foundation posterior stabilized (ps) total knee design, pre-market evaluation, determined that the constraint of the design is primarily attributed to the post.It also determined that the design was similar to other designs showing the capacity to withstand medial/lateral shear forces in excess of normal knee reported maximums.Additionally, test 94-0001, fatigue testing of intercondylar post on foundation posterior stabilized tibial insert, determined that the intercondylar post of the foundation posterior stabilized (ps) tibial insert exhibited sufficient fatigue strength to withstand expected in-vivo loads.Wear mechanisms typically associated with total knee arthroplasty include abrasive wear, adhesive wear, third-body wear, delamination, and fatigue.High cyclic stresses are also known to produce delamination.Many factors can contribute to acceleration of wear mechanisms including patient factors, surgical technique, manufacturing methods, design and time in vivo.) visually inspected, per photos provided, the lateral condyle/medial condyle show a significant amount of surface delamination and fractured post (broken off into one piece).Customer complaint history showed ten (10) other complaints for this part number, eight (8) for broken tibial post none from this lot number.There are no on-going issues that are in need of review.The cause of this complaint was a revision surgery due to a broken cam (post).The root cause cannot be determined with confidence as the implants were not returned for investigation.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION PS KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE10 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7071759
• Report Number: 1644408-2017-01123
• Device Sequence Number: 16343580
• Product Code: JWH
• UDI-Device Identifier: 00888912116299
• UDI-Public: (01)00888912116299
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 07/28/2014
• Device Model Number: 360-09-510
• Device Catalogue Number: 360-09-510
• Device Lot Number: 54009690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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: 213-01-010, LOT 54015516; 323-01-110, LOT 53987890
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 87