• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. REGENEREX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 03/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices -vngd ps open por fmrl lt 62. 5, catalog #: 184526, lot #: 993610; e1 vngd ps+ tib brg 63/67x10, catalog #: ep-183720, lot #: 315430; biomet finned pri stem 80x10mm, catalog #: 141316, lot #: 486030; bmet regenx pri tib tray 67mm, catalog #: 141272, lot #: 060430. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The results of the investigation are as follows: no devices or photos were received; therefore, the condition of the components is unknown. Review of the device history record identified no related deviations or anomalies during manufacturing. Primary operative notes does not suggest any intra operative complications. Office visit notes from the doctor states that x-ray report revealed that all three patella pegs are broken causing loose patella and pain. The root cause of the patella peg fracture was determined to be a labeling and training deficiency as the surgical technique addendum for installation of regenerex patella failed to include guidance on depth line indication on the peg drill bit. A corrective action has been initiated to address the malfunction. 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.
 
Event Description
It was reported a patient received a left total knee arthroplasty. During an office visit it was noted the patients patella has failed. All 3 pegs are off and the looseness of patella is causing her pain. Patient has not underwent a revision procedure to date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREGENEREX 3 PEG SER A PATELLA 28MM
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 Key12214165
MDR Text Key263103333
Report Number0001822565-2021-01953
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2021
Device Model NumberN/A
Device Catalogue Number141355
Device Lot Number619490
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 Received06/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2068-2017

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1
-
-