MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; BASEPLATE, TIBIAL, STEMMED, 3D, SIZE6R NONPOROUS

Model Number	392-09-705
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred over 2 years and 1 month 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.Initial or prolonged hospitalization was required.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.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its 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 loosening.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.Agent has clearly mentioned that "patient was experiencing pain because of tibia loosening " it seems that the event may possibly have occurred due to inadequate soft tissue support, patient age, degenerative bone disease, patient bone deterioration, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to the patient experiencing pain because of tibial loosening.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred over 2 years and 1 month 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.Initial or prolonged hospitalization was required.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.There was a nonconformance associated with the part# 392-09-705, insert ,3d ex size 5right 9millimeter which documents a nonconformance that out of 12 quantities 1 item was rejected and scrapped due to condyle out of tolerance.All other parts were accepted.All other items in the lot were 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 loosening.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.Agent has clearly mentioned that "patient was experiencing pain because of tibia loosening " it seems that the event may possibly have occurred due to inadequate soft tissue support, patient age, degenerative bone disease, patient bone deterioration, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Corrected data: see: common device name, concomitant medical products, device manufacture date.Corrected manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred over 2 years and 1 month 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.Initial or prolonged hospitalization was required.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.A review of the device history records showed no non-conforming material reports associated with the main contributor component, (b)(4), lot 277b1238, listed in the complaint.The device and its applicable concomitant devices were within their 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 loosening.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.Agent has clearly mentioned that "patient was experiencing pain because of tibia loosening ".It seems that the event may possibly occurred due to inadequate soft tissue support, patient age, degenerative bone disease, patient bone deterioration, 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.

• Brand Name: 3D KNEE
• Common Device Name: BASEPLATE, TIBIAL, STEMMED, 3D, SIZE6R NONPOROUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8626264
• Report Number: 1644408-2019-00450
• Device Sequence Number: 2637439
• Product Code: JWH
• UDI-Device Identifier: 00888912120258
• UDI-Public: (01)00888912120258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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: 01/10/2023
• Device Model Number: 392-09-705
• Device Catalogue Number: 333-02-106
• Device Lot Number: 277B1238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 06/04/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/21/2019; 07/03/2019
• 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: 333-02-106, LOT 277B1238; 392-09-705, LOT 327G1046
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR