MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 PERSONA VIVACITE ARTICULAR SURFACE; OIY

Catalog Number 42512400711

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 01/05/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to instability in the left knee.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the implants is unknown.Review of the device history records identified no deviations or anomalies.The devices involved were reviewed for compatibility with no issues noted.This device is used for treatment.A product history search conducted for the articular surface identified no other complaints for this part and lot combination.The primary operative notes indicate that excellent stability, range of motion, and patellar tracking were achieved with the implants.No deviations from the surgical technique were noted during the primary surgery.There is no information regarding the patient¿s adherence to rehabilitation protocol or any other patient factors that may influence the performance of the device.The revision operative notes indicate that there was no sign of infection in the knee, and there were no statements indicating that there were any issues with the explanted devices.Risk of instability is addressed in the persona the personalized knee system package insert.The package insert lists ¿dislocation and/or joint instability¿ as an adverse effect of this procedure.This is therefore a known inherent risk of the procedure.A definitive root cause cannot be determined with the information provided.

• Brand Name: PERSONA VIVACITE ARTICULAR SURFACE
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5607679
• MDR Text Key: 43624332
• Report Number: 0001822565-2016-01317
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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: 09/30/2017
• Device Catalogue Number: 42512400711
• Device Lot Number: 62175930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR