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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 28MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 28MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Fracture (1260)
Patient Problem Reaction (2414)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: e1 vngd ps tib brg 71/75x10 catalog#: ep-183640 lot#: 357950, bmet regenx pri tib tray 75mm catalog#: 141274 lot#: 376360, biomet finned pri stem 40mm catalog#: 141314 lot#: 842180, vngd ps open por fmrl lt 65 catalog#: 184528 lot#: 011600. Reported event was confirmed by review of medical records. Revision operative notes state that patella was noted to be broken off. Also, there was significant amount of blackened synovium from metallosis. Device history record was reviewed and no discrepancies 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. 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 patient underwent a left total knee arthroplasty. Subsequently, the patient was revised due to metallosis and a fractured patella. No additional patient consequences were reported.

 
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Brand NameRGX 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 Key9962571
MDR Text Key187892273
Report Number0001825034-2020-01565
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/04/2020
Device MODEL NumberN/A
Device Catalogue Number141355
Device LOT Number232590
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 Received03/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/04/2015
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: 04/15/2020 Patient Sequence Number: 1
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