MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG CR MONO-LCK BRG 12X75; PROTHESIS KNEE

Catalog Number 189682

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 09/13/2015

Event Type  malfunction  

Manufacturer Narrative

Product was received by zimmer biomet.The complaint of damaged polyethylene is confirmed.The carton displayed significant signs of damage.The inner tray was fully intact and there was no breach of sterile barrier.The seal transfer on the tray displays that a proper seal was created.The cause of the damage to the implant cannot be determined.Therefore, it cannot be determined if the implant left biomet conforming.The polyethylene was removed from the base plate and sectioned to measure the oxidation index close to the overmolded section of the polyethylene where flaking occurred.The oxidation index was measured per zwi 29.524 at the zimmer research facility (work order number (b)(4)).The maximum normalized oxidation index measured across thin sections of the part was 8.44.There was also evidence of white banding on the thin sections.The white banding and oxidation index suggest that the material was exposed to oxygen and oxidized on the shelf.The resulting "flaking" of the polyethylene material was likely the result of oxidation combined with residual stress from direct molding.The barrier film bag used to limit the polyethylene's exposure to oxygen was not returned with the device.The device was returned with the tyvek lid, blister carton, and a nylon bag like those used to wrap femoral components.An investigation of the router shows that the barrier film bag was a part of the bill of materials and that the vacuum sealing step was indicated on the router as complete.This may suggest that the barrier film bag was compromised during the same distribution conditions that led to the packaging damage mentioned in the use synopsis.Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.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.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during an initial tka on (b)(6) 2015; the packaging for the tibial component was damaged and polyethylene flakes were observed on the product.A different implant was used to complete the procedure without delay.

• Brand Name: VG CR MONO-LCK BRG 12X75
• Type of Device: PROTHESIS 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: 6957582
• MDR Text Key: 89702559
• Report Number: 0001825034-2017-09088
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK060525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 189682
• Device Lot Number: 828340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• 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