MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PS KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 11MM CM

Model Number	360-11-506
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was the patient was unstable.The previous surgery and the revision detailed in this investigation occurred over 4 years and 6 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 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.Ncmr# (b)(4) was associated with the part number 360-11-506, insert, posterior stabilized, series 500, size 6 11mm cm which documents a nonconformance that out of (b)(4) quantities lot, 2 parts were rejected and sent to rework due to incorrect usage of (b)(4) for inspection.The other 18 parts were accepted after handling suitable operations.There was a nonconformance in the same part after handling the operations, where 20 quantities lot,1 part was rejected and scrapped due to usage of cruciate notch from first operation.The other 19 parts were accepted after handling suitable operations.All items were reworked and met the design, fit and function requirements.The device was within its respective 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 instability.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are poor bone density, inadequate soft tissue support, patient bone deterioration, degenerative bone, patient activities 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.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - patient was unstable.

• Brand Name: FOUNDATION PS KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8667513
• Report Number: 1644408-2019-00488
• Device Sequence Number: 19400275
• Product Code: JWH
• UDI-Device Identifier: 00888912116343
• UDI-Public: (01)00888912116343
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: 03/31/2019
• Device Model Number: 360-11-506
• Device Catalogue Number: 360-11-506
• Device Lot Number: 59604387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: 70 YR