MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIAL COMPONENT; PROSTHESIS, KNEE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Weight Changes (2607); Unequal Limb Length (4534); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown femoral component: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2022-02137.The product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in process.Upon completion of the investigation or receipt of additional information, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee procedure.Subsequently, the patient has been experiencing popping, clicking, swelling, leg length discrepancy, and weight gain.The patient consulted a doctor who noted loosening in x-ray images.At the time of this report, a revision surgery has not been scheduled and no further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.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: UNKNOWN TIBIAL 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: 15079271
• MDR Text Key: 302841354
• Report Number: 0001822565-2022-02138
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 08/26/2022
• 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 NARRATIVE.
• Patient Sex: Female
• Patient Weight: 81 KG