MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METALA CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00597206529, all poly patella standard size 29 mm, lot # 64129660.00575201506, cruciate retaining cr-flex gender solutions female femoral component, lot # 63058383.Report source: event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00169, 0001822565 - 2020 - 00901.
Event or Problem Description
It was reported that approximately 7 months post implantation, the patient developed an infection of the right knee arthroplasty.The patient underwent a washout of the knee.Subsequently, the patient has now been revised of the knee implants approximately 15 months post initial implantation due to septic loosening.Attempts have been made and no further information has been provided.
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.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays and medical records were provided and reviewed by a healthcare professional.No findings available from medical records due to lack of records provided.X-ray review found radiolucency at the bone-metal interface of the femoral implant suggesting loosening.Bone quality is osteopenic.A definitive 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.

• Brand Name: TRABECULAR METALA CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9824245
• Report Number: 3005751028-2020-00016
• Device Sequence Number: 3068966
• Product Code: MBH
• UDI-Device Identifier: 00889024310087
• UDI-Public: (01)00889024310087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588604510
• Device Lot Number: 63705140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79