MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM; PROSTHESIS, KNEE

Catalog Number 42522400712

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item name: zimmer persona the personalized knee system, catalog number: 42530007502, lot: 62365093.Item name: zimmer persona knee system, catalog number: 42500606202, lot number: 62300759.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2017-01664 and 3007963827-2017-00023.

Event Description

It was reported that the patient underwent a total knee arthroplasty approximately 3 years ago and was revised for pain and instability.During the revision surgery, the surgeon noted the persona trabecular metal tibia was loose.He also determined the persona ps standard femoral component was malpositioned.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as this component was not related to the event.The initial report should be voided.

• Brand Name: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
• 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: 6396803
• MDR Text Key: 69644050
• Report Number: 0001822565-2017-01665
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 42522400712
• Device Lot Number: 62315376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• 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