MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA RIGHT MEDIAL PARTIAL FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

This event was initially reported on manufacturing report number 0001822565-2018-01833, which has since been voided.Manufacturing report number 0001825304-2018-02333 will be kept for investigative purposes.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Remains implanted.

Event Description

It was reported that the drill peg went through the cortex of the tibia when the surgeon was attempting to drill the peg through the provisional.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Concomitant medical products - partial articular surface right medial size h 8 mm thickness catalog# 42528200808 lot# 63573612, partial tibial cemented size h right medial catalog# 42538000802 lot# 63715064.Reported event was confirmed by review of x-rays.The pre-operative x-rays were noted to containt severe medial compartment narrowing of the right knee with varus alignment.It was also noted that bone quality appeared slightly osteopenic.Post-operative x-rays show a non-displaced fracture at the medial condyle.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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: PERSONA RIGHT MEDIAL PARTIAL FEMORAL COMPONENT
• 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: 7396481
• MDR Text Key: 104361830
• Report Number: 0001825034-2018-02333
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK161592
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42558000502
• Device Lot Number: 63507275
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 67