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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. NEXGEN CRUCTIATE RETAINING FLEX FEMORAL COMPONENT PROSTHESIS, KNEE Back to Search Results
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.

 
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Brand NameNEXGEN CRUCTIATE RETAINING FLEX FEMORAL COMPONENT
Type of DevicePROSTHESIS, 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 Key6860630
MDR Text Key85908223
Report Number0001822565-2017-06396
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK072619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
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 Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00575201601
Device LOT Number63277675
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/12/2017 Patient Sequence Number: 1
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