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

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Hyperextension (4523); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A2: year of birth - (b)(6).G2: foreign - denmark.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.Subsequently, x-rays show a broken hinge.It is unknown when it broke.There has been no revision reported to date.Attempts have been made and no further information has been provided.

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently, the patient was revised approximately 2 years post implantation due to pain, swelling, hyper-extension, and clicking noise.During the revision, fracture of the hinge mechanism, wear of the femoral component and metallosis were noted.The patient underwent exchange of the femoral component and liner without complication.The initial tibial component and patella remained implanted.It was reported no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 00588006014 - 14mm height size f articular surface with hinge post extension - 63492976.00598801016 - 16mm diameter 100mm length straight stem extension - 64196723.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The initial report should be voided.Upon investigation of this reported event, it was determined that it was previously reported under 0001822565-2021-01326.

• Brand Name: RIGHT SIZE F CEMENTED OPTION FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17867688
• MDR Text Key: 324874757
• Report Number: 0001822565-2023-02718
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199170
• UDI-Public: (01)00889024199170(17)220731(10)63556176
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588001602
• Device Lot Number: 63556176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG