MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-NATURAL KNEE-BEARINGS-UNK; PRSOTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D6a: implant date - 2003.G2: foreign - 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, associated reports: 0001822565-2023-01955; 0001822565-2023-01956.

Event Description

It was reported the patient underwent a left knee revision approximately 20 years post implantation due to metallosis secondary to poly wear.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 sign of use.Excessive wear were seem on the both tibial plate and articular surface.Also, some wear can be seen on femur condyle.However, product was not returned and further evaluation cannot be made.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: advanced polyethylene wear with tibiofemoral narrowing and knee valgus as noted.Marked osteopenia.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: KNE-NATURAL KNEE-BEARINGS-UNK
• Type of Device: PRSOTHESIS, 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: 17343740
• MDR Text Key: 319283075
• Report Number: 0001822565-2023-01957
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Report Date: 11/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 06/29/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/21/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Female