MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TAPERED STEM EXTENSION; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 was reported that the inner packaging of the device was found damaged during a knee arthroplasty procedure.The device was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of picture.Pictures of the packaging material confirmed the presence of white debris stuck to the plastic retainer.Dhr was reviewed and no discrepancies were found.The retainer was designed in the orientation which results in less clearance between the retainer and the inner tyvek lidstock, causing the lidstock to stick to the retainer and transfer the adhesive during sealing.Therefore, it is considered that a design deficiency is the root cause of the reported issue.A summary of the investigation has been sent to the complainant.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 TAPERED STEM EXTENSION
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7515445
• MDR Text Key: 108366244
• Report Number: 0001822565-2018-02580
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK133737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42557000114
• Device Lot Number: 63656928
• Other Device ID Number: 00889024247734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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