MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528); Separation Failure (2547); Loosening of Implant Not Related to Bone-Ingrowth (4002); Difficult or Delayed Separation (4044)

Patient Problems Necrosis (1971); Pain (1994); Swelling (2091); No Information (3190)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source- (b)(6).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.

Event Description

It was reported that a patient was revised due to femoral loosening.There is no additional information available at this time.

Event Description

It was reported that a patient was revised approximately one year and three months post implantation due to pain and loosening of the femoral and patellar components.During the revision, it was noted that the hinge screw was cold-welded with adjacent necrosis on the medial femoral condyle.The tibial components were left in place, and all other components were revised without complication.

Manufacturer Narrative

This follow-up is being submitted to relay additional information and correct previous information: multiple mdr reports were filed for this event, please see associated report: 0002648920-2021-00016 d11-medical product all poly patella standard size 35 mm diameter 9.0 mm thickness cemented item# 00597206535 lot# 64325356.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images were not sent for further review due to poor quality; patient presented with pain and signs of aseptic loosening of the femoral and patellar implant; very large intra-articular effusion noted, synovasure of fluid tested negative; "attempt to remove the hinge screw.This one is cold welded on the hinge."; necrosis of the internal femoral condyle and bone defects noted; femoral implant removed without difficulty; no sign of loosening or osteolysis of the tibia, left intact; new patella and femoral components placed without further complication.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11196432
• MDR Text Key: 227736121
• Report Number: 0001822565-2021-00192
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: 00588001402
• Device Lot Number: 64230855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• 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