MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Loss of Range of Motion (2032); Scar Tissue (2060); Alteration in Body Temperature (4568); Swelling/ Edema (4577)

Event Date 04/05/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee arthroplasty.Approximately 5 months post implantation, the patient underwent manipulation under anesthesia.The patient reports she is still having swelling, no range of motion, limited mobility, and the knee is hot to the touch.The patient remains implanted with devices.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported a patient underwent a manipulation under anesthesia due to stiffness that was impacting rom from adhesions & scar tissue.Patient remains implanted.Patient reports swollen and hot to the touch with limited range of motion.One month later, knee was aspirated for recurrent pain, swelling, and warmth performed.Upon exam performed by new doctor noted effusion, mild pain with rom, tender to palpation, moderate laxity with varus/valgus stress test and anterior drawer.Patient reports loosening at last office visit.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d4, g3, g6, h1, h2, h6, h11.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: PERSONA FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 9
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19124535
• MDR Text Key: 340377009
• Report Number: 3007963827-2024-00124
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113369
• 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: 05/28/2024

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: 42500006602
• Device Lot Number: 65394877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 90 KG