MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 12MM X +135MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented fixed tibial component right size e catalog #: 42542007102 lot #: 64817975, persona revision trabecular metal tibial central cone size x-small catalog #: 42545000510 lot #: 64800266, persona revision constrained condylar knee articular surface right 12mm catalog #: 42522800712 lot #: 64660505, persona revision cemented femoral component plus right size 9+ catalog #: 42504606612 lot #: 64867234, persona revision offset splined uncemented stem extension 3mm x 14mm x 135mm+ catalog #: 42560313514 lot #: 64799481, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 942bac2502, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 936bae2505.The complainant 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2024-00885, 0001822565-2024-00887.H3 other text : investigation incomplete.

Event Description

It was reported that the patient was prescribed diclofenac, a foam roller and home exercises to address pain, instability, pes and iliotibial band tendonitis approximately two (2) years following right knee arthroplasty.Initial operative notes noted no intraoperative complications.

• Brand Name: PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 3MM X 12MM X +135MM
• 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: 18895480
• MDR Text Key: 337563720
• Report Number: 0001822565-2024-00886
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868250026
• UDI-Public: (01)00887868250026(17)300901(10)64853552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

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: 42560313512
• Device Lot Number: 64853552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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): Required Intervention
• Patient Sex: Male
• Patient Weight: 94 KG