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

Model Number N/A

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Joint Dislocation (2374)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.Onset of bruising after implant on unknown date.

Event Description

It is reported that the after a knee arthroplasty the patient experienced discoloration of the knee a couple times within a month of the primary surgery.The patient was revised due to the discoloration issue.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical products and therapy dates: item # 42-5320-064-01, persona stemmed tibial component, lot #63463583, item# 42-5022-056-01, persona cr porous femoral component, lot#62942822.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It is reported that the after a knee arthroplasty the patient experienced discoloration of the knee a couple times within a month of the primary surgery.The patient was revised due to dislocation.It was reported that the surgeon could not insert the surface in the tibial play completely.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the returned articular surface indicates locking feature was flared at some areas.Some damage (pitting/scratches and gouging) was also noted on the proximal surface.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.A summary of the investigation has been sent to the complainant.A definitive root cause cannot 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 is reported that the after a knee arthroplasty the patient experienced dislocation of the knee a couple times within a month of the primary surgery.The patient was revised due to dislocation.It was reported that the surgeon could not insert the surface in the tibial plate completely during the primary procedure.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA VIVACIT-E ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• 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: 6195265
• MDR Text Key: 62996468
• Report Number: 0001822565-2016-04768
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512000413
• Device Lot Number: 62322798
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 06/13/2017; 10/11/2017; 10/23/2017
• Supplement Dates FDA Received: 02/14/2017; 07/13/2017; 10/13/2017; 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention