MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient age or date of birth: (b)(6).Concomitant medical products: 42558000601 62477806 partial femur cemented size 6 left medial, 42518200408 63449770 partial articular surface left medial size d 8 mm thickness.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient¿s knee was revised approximately 2 years post implantation due to loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was confirmed by review of x-rays received.Radiographs were provided and reviewed by a health care professional.Review of the available records identified that there is extensive lucency along the tibial implant reflecting osteolysis.The tibial implant shows loosening and posterior subsidence with abnormal tilt of the articular surface.Medical records were reviewed by a health care profession.Review of the available records identified the following: initial implantation op notes revealed uncomplicated initial left partial knee replacement on.Cement was used for the tibial and femoral components.At the 3-month post-op visit, there were no reported problems.At the 1-year post-op visit, the patient reported moderate pain.At the 2-year post-op visit, little medial/lateral instability was noted along with radiographic findings of a tibial fracture.The patient underwent revision surgery to replace the tibial component due to loosening.Visual examination of the returned product identified there is cement/bone residue on the femoral component.There is no cement/bone residue on the tibial tray.The tibial tray shows signs of implantation (surface damage).The articular surface is still attached to the tibial tray.The articular surface is slightly discolored and has nicks on its surface.Dimensional analysis of the tibial tray determined that the product, where measured, was conforming to print specifications.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d10; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified there is cement/bone residue on the femoral component.There is no cement/bone residue on the tibial tray.The tibial tray shows signs of implantation (surface damage).The articular surface is still attached to the tibial tray.The articular surface is slightly discolored and has nicks on its surface.Dimensional analysis of the tibial tray determined that the product, where measured, was conforming to print specifications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified that there is extensive lucency along the tibial implant reflecting osteolysis.The tibial implant shows loosening and posterior subsidence with abnormal tilt of the articular surface.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.It was noted that tibial tray did not have trace of any bone cement.Per the ifu, "the persona partial knee system is a single use implant intended for implantation with bone cement." however, as it is unknown if any traces of bone cement were removed prior to the post market surveillance team receiving the product, the root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under 0001825034 - 2020 - 01633 number.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under 0001825034 - 2020 - 01633 number.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9350326
• Report Number: 0001822565-2019-04982
• Device Sequence Number: 11443583
• Product Code: HSX
• UDI-Device Identifier: 00880304812666
• UDI-Public: (01)00880304812666
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161592
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000401
• Device Lot Number: 63607192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/13/2020; 03/30/2020; 03/30/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/19/2020; 04/10/2020; 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 104