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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. REGENERX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: vgd ps open por fem rt 62. 5 catalog # 184506 lot # 592860; bmet regenx pri tib tray 67mm catalog # 141272 lot # 937420; biomet finned pri stem 40mm catalog # 141314 lot # 342620; e1 vngd ps tib brg 63/67x10 catalog # ep-183620 lot # 587500. Customer has indicated that the product will not be returned because product location is unknown. Reported event was confirmed by review of medical records provided. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. 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. The event is being addressed through the capa process. Medical records review indicates that two patella pegs were fractured. There was no synovitis or metallosis seen. 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 that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to two fractured pegs on the patella prosthesis. The patella was removed and replaced.
 
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Brand NameREGENERX 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 Key10372592
MDR Text Key201884268
Report Number0001825034-2020-03017
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 consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2020
Device Model NumberN/A
Device Catalogue Number141355
Device Lot Number044830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2015
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: 08/06/2020 Patient Sequence Number: 1
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