MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA STEMMED 5-DEGREE TIBIA; 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:42522000412 lot number:62342598 brand name: persona articular surface, 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 -06675, 0002648920 - 2019-00649.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.

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.

• Brand Name: PERSONA STEMMED 5-DEGREE TIBIA
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8950223
• MDR Text Key: 156155583
• Report Number: 0002648920-2019-00652
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006702
• Device Lot Number: 63125357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2015
• 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 Outcome(s): Other
• Patient Age: 60 YR