MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA E ALL POLY PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona cps articular surface cat# 42522600716, lot# 62828278.Persona tibial cemented 5 degree stemmed cat#: 42532007102, lot#: 63452344.Persona stem extension tapered cemented 14mm cat#: 42557000114, lot#: 63492928.Persona ps femur cemented cat#: 42500006202, lot#: 63387673.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06824, 3007963827-2018-00220, 0001822565 - 2018 - 06845, 0002648920 - 2018 - 00864, 3007963827 - 2018 - 00221.

Event Description

It was reported that the patient was revised after initial knee procedure due to infection.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The product was evaluated through manufacturing and radiographic review, however, the reported infection could not be confirmed.Radiographic inspection identified evidence of possible loosening of the anterior femoral component as well as the tibial stem and posterior tibial plateau.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Per package insert for the persona knee system, infection is known adverse effect of this system.However, a definitive root cause could not be determined.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 E ALL POLY PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8160781
• MDR Text Key: 130260005
• Report Number: 0002648920-2018-00864
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 42540200035
• Device Lot Number: 63404727
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention