MAUDE Adverse Event Report: ZIMMER, INC. PERSONA VIVACIT-E ARTICLUAR SURFACE POSTERIOR STABILIZED; PROSTHESIS, KNEE

Catalog Number 42512401010

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products:- unknown tibial tray, catalog # unknown, lot # unknown.Unknown femoral, catalog # unknown, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the device remains implant.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 associated reports: 0001822565-2017-04717, 0001822565-2017-04722.

Event Description

It was reported following a left knee arthroplasty, the patient underwent a manipulation.The patient is experiencing loosening, swelling, popping and snapping.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4) the following report is submitted to relay additional information femur cemented posterior stabilized (ps) standard left size 10 lot#62747654 item#42500606801,psn tib stm 5 deg sz g l lot#62954439 item#42532007901 , all-poly patella, ve 38mm x 9.5mm lot#62916598 item#42540200038, headless trocar drill pin 75mm lot#62899977 item#00590102000, 48mm headed screw lot#62916537 item#00579104100, 48mm headed screw lot#62916538 item#00579104100, psn asf ps 12mm ve l 10-12 gh lot#62679125 item#42512401012 the reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.The components were reviewed for compatibility with no issues noted.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2018-00004, 0002648920-2018-00015.

• Brand Name: PERSONA VIVACIT-E ARTICLUAR SURFACE POSTERIOR STABILIZED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6720395
• MDR Text Key: 80246282
• Report Number: 0001822565-2017-04723
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 42512401010
• Device Lot Number: 62866060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 83