MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 31MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Host-Tissue Reaction (1297)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: bmet regenx pri tib tray 71 mm catalog#: 141273 lot#: 504530, biomet finned pri stem 40 mm catalog#: 141314 lot#: 063050, vanguard cr por fem-rt 60 catalog#: 183044 lot#: 860710, e1 vngd as tib brg 10x71 catalog#: ep-189060 lot#: 663740.Customer has indicated that the product will not be returned to zimmer biomet for investigation, because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a knee procedure on an unknown date.Subsequently, the patient was revised due to fracture of the pegs of the patella implant.The joint space was noted to have metallosis and debris.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed from visual photographs provided.Device was not returned back for evaluation.Visual inspection of the photographs for the explanted patella implant provided shows all three patella pegs is fractured from the device.There is bone growth seen on the device.Device history record 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.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: RGX 3 PEG SER A PATELLA 31MM
• Type of Device: PROSTHESIS, 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 Key: 7790310
• MDR Text Key: 117335570
• Report Number: 0001825034-2018-04777
• Device Sequence Number: 1
• Product Code: HRY
• 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: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: N/A
• Device Catalogue Number: 141356
• Device Lot Number: 117460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR