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

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.

• Brand Name: REGENEREX PATELLA COMPONENTS - 3 PEG SER A PATELLA 37MM
• Type of Device: PROSTHESIS, 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 Key: 6578521
• MDR Text Key: 75548928
• Report Number: 0001825034-2017-03377
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• 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 Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 141358
• Device Lot Number: 480460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2068-2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR