MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported the patient underwent an initial right knee arthroplasty.Approximately 2 years post implantation, the patient was revised due to unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Foreign source: australia.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03632, 0001822565-2022-03634, 0001822565-2022-03635.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 the patient underwent an initial right knee arthroplasty.Approximately 2 years post implantation, the patient was revised due to pain.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted femur, tibia, and articular surface covered in bio-debris.No further evaluation can be made from the provided picture.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tka was performed on (b)(6) 2020.A revision was performed on (b)(6) 2022 for pain, and all implants were extracted and replaced with persona revision.The op record was not provided for the revision.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: radiographically unremarkable appearance of right total knee arthroplasty.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.

Event Description

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

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• 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: 16078362
• MDR Text Key: 306436010
• Report Number: 0001822565-2022-03633
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/01/2023; 02/06/2023
• Supplement Dates FDA Received: 01/17/2023; 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 70 KG