MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE H; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00321, 0001822565-2020-04057.Concomitant medical products: femur cemented posterior stabilized (ps) standard right size 8 catalog#: 42500606402, lot#: 62779777, articular surface fixed bearing ps right 10 mm height catalog#: 42522400910, lot#: 62351259.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right knee revision approximately six years¿ post-implantation due to pain, stiffness, and loosening.During the revision, osteolysis was noted under the femoral.Attempts to obtain additional information have been made; however, no more is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product/provided pictures identified that the femur exhibits signs of use (surface scratches) and bone cement remains.Also performed dimensional analysis, results within specification.The tibia component exhibits signs of use (nicked, gouged, scratches) and bone cement remains.Also both pegs have been cut off.The articular surface shows signs of being implanted like nicks or gouges.The dhr was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: findings suggestive of possible loosening of the tibial component with early loosening of the anterior portion of the femoral component.Overall fit and alignment of the right total knee arthroplasty is appropriate.Mild osteopenia.A definitive root cause cannot be determined.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.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE H
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10985072
• MDR Text Key: 220716477
• Report Number: 0001822565-2020-04058
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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 Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530008302
• Device Lot Number: 62648727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention