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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: rhk articular surface, catalog #: 00588006020, lot #: 61966722.(b)(6).Customer has indicated product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation is completed, a follow-up report will be filed.Multiple mdr reports were filed for this report, please see associated reports: 0001822565-2018-07060, 0001822565-2018-07065.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 patient underwent total knee arthroplasty.Subsequently, patient was revised due to pain, loose femur and broken hinge.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the femoral component and hinge post extension exhibited signs of use.The hinge post extension showed a fracture and crack in the femur hinge mechanism, which was due to fatigue.Device history record (dhr) was reviewed and no discrepancies were found.Per package insert, loosening, fracture, and osteolysis are known adverse effects of this system and procedure.However, 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04420, 0002648920 - 2019 - 00745, 0001822565 - 2019 - 04421.

Event Description

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

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8190694
• MDR Text Key: 131203414
• Report Number: 0001822565-2018-07060
• 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
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588001602
• Device Lot Number: 62889401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• 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