MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN CRUCTIATE RETAINING FLEX FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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.Retained by hospital.

Event Description

It was reported that the patient was revised to address a suspected nickel allergy.The femoral component was revised to a titanium component.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.Concomitant medical products: modular tibial plate fixed bearing precoat for cemented item #00596003702 lot #63308701, articular surface use with lps/lps-flex 51 or 52 suffix femorals item #00596203010 lot #63229165, nexgen prolong all_poly patella 32 mm item #00597206632 lot #63396062, taper stem plug item #00596009900 lot #63403287, 3.5 mm hex head screw 3.2 mm diameter 33 mm length item #00590103533 lot #unk, headless trocar drill pin 3.2 mm diameter 75 mm item #00590102000 lot#unk.The reported event could not be confirmed based on limited information received.No product was returned; therefore, the visual and dimensional evaluations could not be performed.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.The reported components were reviewed for compatibility with no issues noted.Review of the complaint history determined that no further action is required.The root cause of the reported issue is attributed to patient allergy.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 CRUCTIATE RETAINING FLEX FEMORAL COMPONENT
• Type of Device: PROSTHESIS, 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: 6860630
• MDR Text Key: 85908223
• Report Number: 0001822565-2017-06396
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00575201601
• Device Lot Number: 63277675
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR