MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CR RIGHT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G3: 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.

Event Description

It was reported that the patient was unhappy with their knee and underwent a revision surgery approximately 7 months post implantation due to pain.The surgeon increased the poly thickness after resecting the pcl.It was reported that no further information is available.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CR RIGHT 12 MM HEIGHT
• 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: 19133827
• MDR Text Key: 340494048
• Report Number: 3007963827-2024-00128
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024241572
• UDI-Public: (01)00889024241572(17)271026(10)65544577
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 42522000412
• Device Lot Number: 65544577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 61 KG