MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Previously reported: 3007963827-2020-0069-2.Udi # (b)(4).Concomitant medical products: item: 42500607002, lot 63590349.Item: 42532007502, lot 63949714.Foreign report source: (b)(6).Visual evaluation of provided picture shows a damaged articular surface and it was a fracture on the medial end.Some discoloration was seen on the articular surface.Tibial tray found to have bone cement/bone attached to the bottom.No other information can be obtained.Additionally, damages seen in the articular surface could be related to damage after the poly disengagement.However, no definite statement can be made as the product was not returned.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined as it is unknown if the implants contributed to the patient fall.Per package insert persona the personalized knee system: dissociation and fracture of the implant are known adverse causes of the system.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.

Event Description

It was reported that patient underwent right total knee arthroplasty; subsequently, the patient had a fall and was revised due to the poly becoming dislodged.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10168046
• MDR Text Key: 195569968
• Report Number: 3007963827-2020-00160
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522400810
• Device Lot Number: 63880501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention