MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS-CPS BOX PROVISIONAL LEFT SIZE 8-9; KNEE INSTRUMENTS

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Sem / eds analysis of the debris found on the instruments was performed and observed that the various effected areas were filled with debris which predominantly showed oxides and some areas showed chlorine.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 root cause is attributed to a maintenance due to following reason.All the metallic instruments contained in the trays show water marks.Some of the chemical elements (ca, s, o) do not come from the instruments themselves, but could come from caso4 contained in hard water.The black residue is ¿uniformly¿ spread on each and all the instruments, which is only possible through contact with air and water.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.

Event Description

It was reported that during the initial operating room (o.R.) setup the nurse was handling the persona femoral provisionals and noticed black residue on her gloves.On the inside of the femoral provisionals black debris was noticed in all left and right femoral provisionals.All 5 sets were examined and all had the same black debris.

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.

• Brand Name: PS-CPS BOX PROVISIONAL LEFT SIZE 8-9
• Type of Device: KNEE INSTRUMENTS
• 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: 7349559
• MDR Text Key: 103026853
• Report Number: 0001822565-2018-01605
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK123459
• 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
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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: 42504700911
• Device Lot Number: 63312165
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1