MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SPLINED KNEE STM 12X80; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bacterial Infection (1735); Osteolysis (2377)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: event date - (b)(6) 2017; 183302 - femoral component - 985620; 185026 - bearing - 437850; 141481 - tibial tray - 305890; 184762 - patella - 377690; 141610 - stem - 172080; 141491 - tibial tray adaptor - 019240; 141741 - tibial block - 117450; 141741 - tibial block - 705130; 184122 - femoral augment - 102230; 184102 - femoral augment - 262840.The product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04067, 0001825034-2020-04068, 0001825034-2020-04069, 0001825034-2020-04070, 0001825034-2020-04071, 0001825034-2020-04073, 0001825034-2020-04074, 0001825034-2020-04075, 0001825034-2020-04076, 0001825034-2020-04077.
Event or Problem Description
It was reported that patient underwent total knee arthroplasty.Approximately 10 months post implantation, the patient underwent a revision procedure where all devices were removed and patient was without hardware for approximately one year to clear infection.The patient was reimplanted approximately 3 years ago.Patient states she has had a (b)(6) infection for the past 3 years.She noted that she has to be revised again and is possibly looking at an amputation.She also relayed that the extra long stems implanted are rocking in her bones and causing damage to her bones.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated.D6: explant date - (b)(6) 2020.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.The root cause of the infection was determined to not be device related.However, a definitive root cause cannot be determined for the loosening.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
It was reported that the patient underwent a knee revision.All components were removed and her knee was fused.Attempts have been made and no further information has been provided.

• Brand Name: BMT SPLINED KNEE STM 12X80
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10819459
• Report Number: 0001825034-2020-04072
• Device Sequence Number: 16625920
• Product Code: JWH
• UDI-Device Identifier: 00880304001312
• UDI-Public: (01)00880304001312(17)250831(10)206110
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K915132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 141612
• Device Lot Number: 206110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 03/23/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 98