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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Hyperextension (4523); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001822565-2023-02718
• Device Sequence Number: 7041947
• Product Code: KRO
• UDI-Device Identifier: 00889024199170
• UDI-Public: (01)00889024199170(17)220731(10)63556176
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 01/16/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/02/2023; 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG