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

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Pain (1994)

Event Date 04/02/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11753818
• MDR Text Key: 248814165
• Report Number: 0001825034-2021-01320
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812659
• UDI-Public: (01)00880304812659(17)270131(10)63419140
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 69