MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CR VE ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Neck Stiffness (2434); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 42502006402 lot number: 62763632 brand name: persona cr narrow femoral.Catalog number:42532006702 lot number:63125357 brand name: persona stemmed.Catalog number:42540000032 lot number:63064362 brand name: persona all poly.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06673, 0001822565-2018-06674, 0001822565-2018-06676.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that the patient is suffering from pain, stiffness and limited activity in daily life approximately 2 years post initial surgery.The surgeon stated this was not related to the device.No revision occurred, implant remains in patient.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication noted during primary surgery.Office visits notes stated that the patient experienced pain constantly and decreased in daily activities.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: PERSONA CR VE ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8124439
• MDR Text Key: 129039372
• Report Number: 0001822565-2018-06675
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 42522000412
• Device Lot Number: 62342598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR