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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. NEXGEN CR-FLEX FEMORAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Catalog Number 00575201502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abdominal Pain (1685)
Event Date 03/03/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products - nexgen articular surface, catalog # 90597003010, lot # 63786789. Nexgen stemmed tibial component, catalog # 00598603702, lot # 63851973. Nexgen all poly patella, catalog # 00597206532, lot # 63841081. Foreign source- (b)(4). Our investigation is ongoing. A follow-up/final report will be submitted when additional information becomes available. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04890, 0002648920-2018-00681, 0002648920-2018-00682.

 
Event Description

It was reported that the patient underwent an initial right knee arthroplasty. Subsequently, a few days later, the patient started to experiences unknown complications. These complications resulted in an antibiotic treatment. The patient also experienced stomach pain. Attempts have been made and additional information on the reported event is unavailable. No additional patient consequences were reported.

 
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Brand NameNEXGEN CR-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 Key7854746
MDR Text Key119494707
Report Number0001822565-2018-04891
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberPK072619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00575201502
Device LOT Number63583982
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/06/2017
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: 09/07/2018 Patient Sequence Number: 1
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