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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGENEREX PATELLA COMPONENTS - 3 PEG SER A PATELLA 37MM PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS REGENEREX PATELLA COMPONENTS - 3 PEG SER A PATELLA 37MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 141358
Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 08/31/2015
Event Type  Injury  
Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4).

 
Event Description

It was reported a patient who underwent a total knee arthroplasty was revised approximately 2. 5 years post implantation for patella peg fracture. During the revision surgery metallosis was found in synovium and removed. Patella was in place but loose. Metal backing showed minimal evidence of any bone ingrowth.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of operative notes. Revision op-notes for this patient determined that: metallosis was found in synovium during revision and removed, the patella was in place but loose, and the metal backing showed minimal evidence of any bone ingrowth. Surgeon attempted to remove the 3 prongs of the metal backed patella. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. The root cause of the reported issue is attributed to 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 device has since been recalled. 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.

 
Search Alerts/Recalls

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Brand NameREGENEREX PATELLA COMPONENTS - 3 PEG SER A PATELLA 37MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6578521
MDR Text Key75548928
Report Number0001825034-2017-03377
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 DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device Catalogue Number141358
Device LOT Number480460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2013
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: 05/19/2017 Patient Sequence Number: 1
Treatment
FINNED PRI STEM 40MM, ITEM 141265, LOT 793610; POR PRI TIB TRAY 79MM, ITEM 141265, LOT 801060; TI LOW PROFILE SCREW, ITEM 103531, LOT 998470; TI LOW PROFILE SCREW, ITEM 103534, LOT 763940; TI LOW PROFILE SCREW, ITEM 103534, LOT 863970; VANGUARD CR POR FEM-RT 65, ITEM 183048, LOT 781610; VNGD CR TIB BRG 12X79/83, ITEM 183462, LOT 545930
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