MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 14MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Discomfort (2330); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomittant devices - persona posterior stabilized cemented standard femoral component left size 10 catalog #: 42500606801 lot #: 63477298, persona cemented stemmed tibial component left size g catalog #: 42532007901 lot #: 63437281,persona cemented all-poly patella 41mm catalog #: 42540200041 lot #: 63084045.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: 3007963827-2023-00086, 3007963827-2023-00087, 0001822565-2023-01065.H3 other text : investigation incomplete.

Event Description

It was reported that the patient is scheduled to undergo a left knee arthroplasty revision to address stiffness, swelling, discomfort and recurrent effusions approximately five years post-operatively.Attempts have been made, however, no additional information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographic review identified no abnormalities and good implant positioning with a suggestion of cortical thinning and osteopenia.The debris identified within the large joint effusion and synovial thickening suggests synovitis.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 14MM
• 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: 16763148
• MDR Text Key: 313519914
• Report Number: 0001822565-2023-01064
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237520
• UDI-Public: (01)00889024237520(17)200531(10)63074166
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 42512401014
• Device Lot Number: 63074166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 102 KG