MAUDE Adverse Event Report: ZIMMER, INC. PERSONA FEMORAL PROVISIONAL LEFT SIZE 5; INSTRUMENT, KNEE

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi #): (b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event.

Event Description

It was reported during initial operating room setup, the nurse handling the femoral provisional had black residue on her gloves.There was noticed to be black debris on the inside of the left and right femoral provisional.There were five sets examined and all five sets had the same black debris.As a result of the event, a delay in procedure occurred approximately thirty to 60 minutes long.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional: updated corrected conclusion code 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.The actual device was not returned for evaluation; however, a 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 as no were trends identified.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 (b)(4) 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.The actual device was not returned and the date should be blank.

• Brand Name: PERSONA FEMORAL PROVISIONAL LEFT SIZE 5
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6775362
• MDR Text Key: 82110102
• Report Number: 0001822565-2017-05334
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: N/A
• Device Catalogue Number: 42504705801
• Device Lot Number: 63501327
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• 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): Required Intervention