MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 5MM HALF TIBIAL AUGMENT BLOCK; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00428, 0001822565-2024-00429, 0001822565-2024-00430, 0001822565-2024-00432.D10-medical product: unknown femoral.Unknown 14mm articular surface.Unknown persona size e tibial tray.Unknown 12mm uncemented stem.Unknown bone cement.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient is experiencing pain, stiffness, instability, swelling, range of motion issues, and difficulty ambulating approximately five months post revision.Five months post op the patient began to feel like the knee was moving out of place which was followed by a fall a month later.The patient continued to have complications with pain, stiffness, difficulty walking, weakness, effusions, limited range of motion, and recurrent falls.The patient went through an additional series of physical therapy.There were no significant findings on radiographic imaging, and the patient was thought to have regional pain syndrome and referred to her pain management physician for appropriate treatment.No completed or planned surgical intervention has been reported at this time.There is no additional information available.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: feels knee moving out "out of place", several falls, stiffness, severe pain, difficulty walking, weakness, rom impairments, swelling.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The complaint is confirmed via medical records.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN 5MM HALF TIBIAL AUGMENT BLOCK
• 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: 18657948
• MDR Text Key: 334729962
• Report Number: 0001822565-2024-00431
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 02/14/2024
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American