MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL CEMENTED SIZE H LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 11/24/2017

Event Type  Injury  

Event Description

It was reported that the patient fell approximately two months following left partial knee arthroplasty after feeling unstable.X-rays were taken and no intervention was required.The patient remained generally dissatisfied, but demonstrated improvement in pain and function.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Concomitant medical products: persona partial knee cemented femur size 3 left medial catalog#: 42558000301, lot#: 63690609, persona partial knee articular surface left medial size h 9mm catalog#: 42518200809, lot#: 63621664, unknown palacos bone cement catalog#: ni lot#: ni.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: 0001825034-2023-00547, 0001822565-2023-00759.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The reported event was confirmed through review of medical records.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.

Event Description

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

• Brand Name: PERSONA PARTIAL KNEE TIBIAL CEMENTED SIZE H LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16572461
• MDR Text Key: 312228439
• Report Number: 0001825034-2023-00548
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812741
• UDI-Public: (01)00880304812741(17)270531(10)63673971
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• 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,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000801
• Device Lot Number: 63673971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• 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 Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White