MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA LM; OXFORD CEMENTED TIBIAL TRAYS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: the product has not yet been returned to zimmer biomet for investigation.Concomitant medical products associated products: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 372870; medical product: oxf anat brg lt sm size 3 pma, catalog #: 159540, lot #: 800510.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 that a patient underwent an initial right knee arthroplasty on an (b)(6) 2018.Subsequently, a revision procedure due to subsided tibial component was performed on (b)(6) 2021.Uni conversion to tka with screws.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided, a review of device history records and complaint history.In addition, we have not been provided with x-rays, any supporting documentation or information on cement used which could provide additional information.The device was revised after approximately 3 years and 4 months prior to revision.A review of the manufacturing history records for the oxford uni tibial tray has been checked and verifies that the component was manufactured and released in accordance with the applicable specifications.The mhr contains no deviations, rejects or concessions.A review of the complaints history over the last 3 years shows 2 complaints reported with the same item number (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product location unknown.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on an (b)(6) 2018.Subsequently, a revision procedure due to subsided tibial component was performed on (b)(6) 2021.Uni conversion to tka with screws.

• Brand Name: OXF UNI TIB TRAY SZA LM
• Common Device Name: OXFORD CEMENTED TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11876025
• Report Number: 3002806535-2021-00228
• Device Sequence Number: 1100011
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: 05019279388844
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 379420
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention