MAUDE Adverse Event Report: ZIMMER, INC. PERSONA PERSONALIZED VIVACIT-E CROSSLINKED ARTICULAR SURFACE FIXED BEARING LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi #):(b)(4).(b)(6).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.We do not know packaging is not to specifications, mdr to void.Device location unknown.

Event Description

It was reported that during an investigation of the stock, debris was found in the sterile package.This was found outside of any procedure, and thus had no patient involvement or associated serious injury.

Manufacturer Narrative

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

Complaint sample was evaluated and the reported event was confirmed.The articular surface was returned, and it was determined that the debris was found inside sealed cavity.The ftir testing was performed and determined that the residue was in the inner cavity of packaging.Specifically, it was located on the inside of the inner cavity lid.The ftir spectrum of the debris is consistent with the ftir spectrum of polyethylene.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Investigation results concluded that the reported event was due to operator error, as this is considered an isolated incident.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 PERSONALIZED VIVACIT-E CROSSLINKED ARTICULAR SURFACE FIXED BEARING LEFT
• 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: 6839434
• MDR Text Key: 84968696
• Report Number: 0001822565-2017-06141
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42512600614
• Device Lot Number: 63560619
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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