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

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: unknown, unknown palacos r bone cement, lot#: unknown; item#: 42558000202 partial femur cemented size 2 right medial lot#: 63458357; item#: 42528200311 partial articular surface right medial size c 11 mm lot#: 63435449.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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: 0001822565 - 2021 - 01225.
Event or Problem Description
Initial right partial knee arthroplasty performed 3.5 years ago.Subsequently, the patient was revised due to pain, subsidence, and loosening of the tibial component.A conversion to total knee arthroplasty occurred without complication.
Additional Manufacturer Narrative
The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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
It was reported that the patient underwent a right knee arthroplasty revision to address pain, subsidence and loosening of the tibial component 3.5 years post-operatively.All components were removed and replaced.Initial operative notes did not identify any intraoperative complications.Revision operative notes noted that the tibial component had collapsed in the posterior medial corner and caused some lifting up of the anterior portion with loosening of the component overall.The femoral component was well-fixed and the patient had no evidence of infection.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE C RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11753818
• Report Number: 0001825034-2021-01320
• Device Sequence Number: 14487830
• Product Code: HSX
• UDI-Device Identifier: 00880304812659
• UDI-Public: (01)00880304812659(17)270131(10)63419140
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/03/2021

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 Model Number: N/A
• Device Catalogue Number: 42538000302
• Device Lot Number: 63419140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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; Required Intervention
• Patient Weight: 69