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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 34MM PROSTHESIS-KNEE

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ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 34MM PROSTHESIS-KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Defective Device (2588); Insufficient Information (3190)
Patient Problems Injury (2348); Reaction (2414); No Information (3190)
Event Date 08/28/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-08869, 0001825034-2018-08870, 0001825034-2018-08871, 0001825034-2018-08872. (b)(4). Concomitant medical products: e1 vngd ps tib brg 79/83x10 item# ep-183660 lot# 534320. Bmet regenx pri tib tray 79mm item# 141275 lot# 360260. Biomet finned pri stem 40mm item# 141314 lot# 539880. Vngd ps open por fmrl lt 67. 5 item# 184530 lot# 100060. Customer has not indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that patient underwent initial left knee procedure and subsequently underwent a revision for an unknown reason. No additional information is available at this time.

 
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Brand NameRGX 3 PEG SER A PATELLA 34MM
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 Key7893047
MDR Text Key120829396
Report Number0001825034-2018-08868
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK083782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2020
Device MODEL NumberN/A
Device Catalogue Number141357
Device LOT Number328720
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 Received09/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2015
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: 09/20/2018 Patient Sequence Number: 1
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