MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 11MM MC TIBIAL INSERT WITH LOCKING MECHANISM VERIFIED; PROSTHESIS KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported patient underwent a manipulation under anesthesia post implantation due to increased pain with intolerance to exercises.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).Medical product: unknown femoral component catalog # unknown lot # unknown.Unknown tibial component catalog # unknown lot # unknown.Report source: australia.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-02929, 0001822565-2022-02961.

Event Description

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3007963827-2022-00306.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3007963827-2022-00306.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 - medical product: unknown size 9 narrow cr tm uncemented femoral catalog # unknown lot # unknown.Size d uncemented tibial catalog # unknown lot # unknown.29mm size all-poly cemented patellar component catalog # unknown lot # unknown.

Event Description

It was reported patient underwent a manipulation under anesthesia post implantation due to increased pain with intolerance to exercises and arthrofibrosis.Attempts to obtain additional information have been made; however, no more is available.Due to arthrofibrosis.

• Brand Name: 11MM MC TIBIAL INSERT WITH LOCKING MECHANISM VERIFIED
• 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: 15605618
• MDR Text Key: 301729217
• Report Number: 0001822565-2022-02927
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female