MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED SIZE G RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that initial uka operation was performed.Postoperatively, follow-up confirmed that the tibia plate was sinking.And a revision was performed one year, one month post implantation.At the revision, the surgeon found a lot of wear on the removed articular surface.
Additional Manufacturer Narrative
(b)(4).Japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 42528200709 partial articular surface right medial size g 9mm lot# 64883414.Mdr: 0001822565-2023-01415.Additional associated products: unk femoral lot# unk.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No devices or photographs were received; therefore, the condition of the components is unknown.Review of the device history record identified no deviations or anomalies during manufacturing.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history found no additional related issues for this items and the reported part and lot combinations.Medical records were not provided.This complaint cannot be confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE G RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17004257
• Report Number: 3007963827-2023-00135
• Device Sequence Number: 14993470
• Product Code: HSX
• UDI-Device Identifier: 00880304812734
• UDI-Public: (01)00880304812734(17)311213(10)65141604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 42538000702
• Device Lot Number: 65141604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male