MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE2 11MM CM

Model Number	385-11-502
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - patient presented 16 years post-operation with pain due to instability.Surgeon determined thicker insert was needed.
Additional Manufacturer Narrative
Corrected data: see d.1 & g.1.Manufacturer narrative: the reason for this revision surgery was reported as pain.The previous surgery and the surgery detailed in this event occurred 15.9 years apart.The healthcare professional indicated there was 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.The device was disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the reported event.The surgeonperformed this revision to remedy the patient condition.This complaint will be closed pending receipt of additional information.Additional reportind on this item will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as pain due to instability.The previous surgery and the surgery detailed in this event occurred 15.9 years apart.The healthcare professional indicated there was 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.The device was disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient condition.This complaint will be closed pending receipt of additional information.Additional reportind on this item will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE2 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10875550
• Report Number: 1644408-2020-01071
• Device Sequence Number: 4329397
• Product Code: JWH
• UDI-Device Identifier: 00888912117821
• UDI-Public: (01)00888912117821
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2021

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 Model Number: 385-11-502
• Device Catalogue Number: 385-11-502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 02/12/2021; 04/02/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 03/12/2021; 09/15/2021
• 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: Other; Required Intervention
• Patient Age: 58 YR