MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION POSTERIOR STABILIZED KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM

Model Number	360-13-506
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - it was reported the best before date was until june 2018.Now the movement was no longer fluid, but rather choppy.During an inspection, it was noticed that the peg of the pe sliding surface was broken.Per bfarm case number: (b)(4), patient reported a sudden increasing feeling of instability of the knee joint after standing up.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as attributable to an insert implanted after the sterility expiration date.The previous surgery and the surgery detailed in this event occurred 2 years and 10 months 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 hospital and not made available to djo surgical for examination.A review of the implant device history record (dhr) shows that the reported component, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) or other discrepancies noted for this lot.The uhmwpe test certificate (attached) showed the material met djo surgical specifications to ms002 rev.D.Sterility certificate of processing (attached) shows the device was verified to have gone through an acceptable sterilization process.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 is attributable to an insert implanted after the sterility expiration date.There were no findings during this investigation that indicate the reported device was defective.The decision to implant was made by the surgeon with full knowledge of the situation.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FOUNDATION POSTERIOR STABILIZED KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• MDR Report Key: 11967542
• Report Number: 1644408-2021-00439
• Device Sequence Number: 3604456
• Product Code: JWH
• UDI-Device Identifier: 00888912116411
• UDI-Public: (01)00888912116411
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 360-13-506
• Device Catalogue Number: 360-13-506
• Device Lot Number: 59603479
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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