MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item # 42502606602 lot # 62945429, item # 42532007502 lot # 63078128, item # 42540000032 lot # 63104082.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00196, 0002648920-2019-00454, 0002648920-2019-00479.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary surgical note was provided and found no complication.The office visit notes states that there is a delay in the healing wound.Device history record was reviewed and no discrepancies were found.No product was returned; visual and dimensional evaluations could not be performed.A definitive root cause cannot be determined.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.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.

Event Description

It was reported that approximately one month post implantation, a patient required medical treatment due to delayed wound healing.The patient was treated with wet to dry wound dressings during a post operative office visit.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT
• 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: 8739081
• MDR Text Key: 149337646
• Report Number: 0002648920-2019-00455
• Device Sequence Number: 1
• Product Code: MBH
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 42521000510
• Device Lot Number: 62846474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• 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; Required Intervention
• Patient Age: 68 YR