MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; STEM, MODULAR,TIBIAL SIZE18MM 60MM

Model Number	320-10-018
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional 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
Primary surgery - after opening implant to the back table, technician noticed holes in the packaging.Item was not implanted but crossed the sterile field.
Additional Manufacturer Narrative
The reason for this complaint was a primary surgery reported as implant's packaging was difficult to identify.The healthcare professional was present in the surgery and was able to source a suitable replacement device after the incident implant's packaging showed signs of damage.The event occurred during surgery, near the patient.The surgery was completed as intended, without delay.No adverse event or patient risk were reported and the device was inspected prior to use and was deemed unacceptable based on the appearance of its packaging.The device was returned to manufacturer and made available at djo surgical for examination.A review of the incident implant's device history record (dhr) shows that the implant's production generated no non-conforming material report (ncmr) that may have contributed to the reported event.Customer complaint history of the reported device showed no present trends or on-going issues requiring review.There have been no complaints filed against other devices from the implant's production lot.No prior complaints have described holes in the packaging of tibial stems.The root cause of this complaint is difficult to identify because the implant's packaging was not returned to djo for examination.It's possible that the implant's packaging was damaged during shipping, or by rough handling by agents and/or surgical personnel.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the incident implant was returned to djo for examination.However, only the implant itself was returned, not the packaging.Therefore, the complaint cannot be verified by the return of the device because its packaging was discarded and cannot be studied by the complaint handling team.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint: after opening implant to the back table, technician noticed holes in the packaging.Item was not implanted but crossed the sterile field.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was implant's packaging was difficult to identify.The healthcare professional was present in the surgery and was able to source a suitable replacement device after the incident implant's packaging showed signs of damage.The event occurred during surgery, near the patient.The surgery was completed as intended, without delay.No adverse event or patient risk were reported and the device was inspected prior to use and was deemed unacceptable based on the appearance of its packaging.The device was returned to manufacturer and made available at djo surgical for examination.A review of the incident implant's device history record (dhr) shows that the implant's production generated no non-conforming material report (ncmr) that may have contributed to the reported event.Customer complaint history of the reported device showed no present trends or on-going issues requiring review.There have been no complaints filed against other devices from the implant's production lot.No prior complaints have described holes in the packaging of tibial stems.The root cause of this complaint is difficult to identify because the implant's packaging was not returned to djo for examination.It's possible that the implant's packaging was damaged during shipping, or by rough handling by agents and/or surgical personnel.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the incident implant was returned to djo for examination.However, only the implant itself was returned, not the packaging.Therefore, the complaint cannot be verified by the return of the device because its packaging was discarded and cannot be studied by the complaint handling team.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FOUNDATION KNEE
• Common Device Name: STEM, MODULAR,TIBIAL SIZE18MM 60MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 11919131
• Report Number: 1644408-2021-00508
• Device Sequence Number: 16944429
• Product Code: JWH
• UDI-Device Identifier: 00888912114455
• UDI-Public: (01)00888912114455
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/29/2021

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: 09/30/2021
• Device Model Number: 320-10-018
• Device Catalogue Number: 320-10-018
• Device Lot Number: 154B1028
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 10/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/20/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female