MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNWON PERSONA ARTICULAR SURFCACE; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).D6a: implant date - (b)(6) 2023.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, please see associated reports: 0001822565-2024-00733.0001822565-2024-00734.

Event Description

It was reported a patient had an initial left total knee arthroplasty.Subsequently, the patient began experiencing pain and swelling and developed a hematoma.At a post-operative visit, the hematoma was lanced to improve stiffness and range of motion.Approximately 2 months post implantation, the patient underwent a knee aspiration with positive infection markers.Approximately 3 months later, the patient underwent a biopsy where staph crepitus and cutbacterium grew.Stage i of a two stage revision was completed 6 months post implantation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided photograph identified an explanted femoral, tibial, and articular surface implant.However, the photograph was insufficient to complete a detailed visual examination of the product.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: pain and swelling, hematoma lanced to help with stiffness and improve rom, aspiration positive.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: UNKNWON PERSONA ARTICULAR SURFCACE
• 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: 18830623
• MDR Text Key: 336862119
• Report Number: 0001822565-2024-00735
• 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
• Report Date: 03/04/2024

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: UNKNWON
• 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: 02/14/2024
• Initial Date FDA Received: 03/04/2024
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male