MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA PS ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona ps standard femoral catalog # 42500606602 lot # 63945461.Persona stemmed tibia catalog # 42532007502 lot # 64214396.Persona all poly patella catalog # 42540000035 lot # 64358545.Customer has indicated that the product will not be returned because product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2019-00254.3007963827-2019-00255 0002648920-2019-00657 device evaluated by manufacturer? remains implanted.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient was experiencing stiffness in knee and underwent a manipulation.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

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.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records review indicates there is no complication noted from primary surgery.Patient underwent mua for stiffness issues.Crf report suggests patient experiencing pain, limited range of motion.Also, the patient was obese.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 PS ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 8970124
• MDR Text Key: 156762926
• Report Number: 3007963827-2019-00256
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522400712
• Device Lot Number: 64242659
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• 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
• Patient Age: 62 YR
• Patient Weight: 104