MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VIVACIT-E MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 13MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Numbness (2415)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: persona natural stemmed cemented tibial component 5 degree left size e catalog #: 42532007101 lot #: 63727131, persona posterior cruciate retaining narrow porous femoral component left size 6 catalog #: 42502206001 lot #: 62504834, persona tapered cemented stem extension 14mm x 30mm catalog #: 42557000114 lot #: 63829925.It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices currently remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event; please see all reports associated with this event.3007963827-2018-00135, 0001822565-2018-04434, 0001822565-2018-04435, 0001822565-2018-04436.Device remains implanted.

Event Description

It is reported that the patient was treated conservatively for pain, numbness and weakness that had developed in the left foot twelve (12) days following left knee arthroplasty.No additional patient consequences were reported.

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 product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 VIVACIT-E MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 13MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7790744
• MDR Text Key: 117383145
• Report Number: 0001822565-2018-04435
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42512100713
• Device Lot Number: 63307817
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86