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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 31MM PROSHTESIS, KNEE

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ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 31MM PROSHTESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product vngd ps open por fmrl rt 67. 5 item# 184510 lot# 494730; bmet regenx pri tib tray 71mm item# 141273 lot# 360190; biomet finned pri stem 40mm item# 141314 lot# 943150; rgx 3 peg ser a patella 31mm item# 141356 lot# 870260; e1 vngd ps+ tib brg 71/75x14 item# ep-183744 lot# 575950. Customer has indicated that the product will not 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 a patient underwent a right knee revision procedure approximately five years¿ post-implantation due to pain, implant fracture, scar tissue, and loosening. There is no additional information available at this time.
 
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Brand NameRGX 3 PEG SER A PATELLA 31MM
Type of DevicePROSHTESIS, 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 Key11464660
MDR Text Key239392266
Report Number0001825034-2021-00732
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2020
Device Model NumberN/A
Device Catalogue Number141356
Device Lot Number870260
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 Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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: 03/11/2021 Patient Sequence Number: 1
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