MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN PRECOAT STEMMED TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.The following sections could not be completed with the limited information provided: date of birth-ni.Weight-ni.Date implanted ¿ na.Date explanted ¿ na.Device received but not yet evaluated.

Event Description

It is reported that the implant had a variation of coating on the underside of the device.No adverse events were reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned and examination of the returned part determined that orange peel shades were observed on the distal side of the tibial component.There were some stains or marks also observed on the blasted area of the distal side.No major defects or damages observed on the proximial side.Dimensions, where measured, were found conforming to print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.The complaint is considered confirmed as the pmma coating of the returned device doesn't have a uniform appearance and is cosmetically unattractive.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.As the returned product was found to be within specifications, root cause was determined to be no problem found.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: NEXGEN PRECOAT STEMMED TIBIAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6231379
• MDR Text Key: 64128900
• Report Number: 0002648920-2017-00008
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00595003701
• Device Lot Number: 63278059
• Other Device ID Number: (01)00889024207110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 12/22/2017
• Supplement Dates FDA Received: 12/21/2017; 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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