MAUDE Adverse Event Report: . PS-CPS FEMORAL PROVISIONAL RIGHT SIZE 5; KNEE INSTRUMENT

Model Number N/A

Device Problems Residue After Decontamination (2325); Device Packaging Compromised (2916)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned parts determined that they had scratches suggesting repeated use.Sem micrographs and eds elemental analysis of the debris on the femoral provisionals was conducted and it was found that rust like indication on the laser etched areas which showed high concentration of (o- oxygen, mn-manganese and cl-chlorine) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed chlorine- cl, carbon-c, silicon- si, calcium-ca and aluminum-al.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.Investigation results concluded that the reported event was due to maintenance issue as some of the chemical elements do not come from the instruments, but could come from hard water.The black residue is spread on each and all the instruments, which is only possible through contact with air and water.The recommended cleaning steps were not followed based on the provided information.This issue only occurred for 1 set out-of 740 sets distributed worldwide in 2017, and in one location where the sterilization equipment of the hospital underwent maintenance one week prior to the 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.

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

Correction,the initial alert date was (b)(4)2018.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

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

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 during initial operating room setup, the nurse handling the instruments discovered black residue on her gloves.Subsequently, there was noticed to be black debris on some of the instruments.There were five sets examined and all five sets had the same black debris.As a result of the event, the surgery was delayed 35 minutes.Multiple cases and instruments were returned for the reported issue, however it is unclear if these instruments contributed to the reported surgical delay.No additional patient consequences were reported, and the surgery was successfully completed.

• Brand Name: PS-CPS FEMORAL PROVISIONAL RIGHT SIZE 5
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): .; 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: 7339033
• MDR Text Key: 102447228
• Report Number: 0001822565-2018-01537
• Device Sequence Number: 1
• Product Code: OIY
• 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,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42504705802
• Device Lot Number: 63561908
• Other Device ID Number: (01)00889024231061
• 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: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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
• Patient Outcome(s): Hospitalization