MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CRUCIATE TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard posterior stabilized tibial bearing, catalog #: ep-183660, lot #: 915390, vanguard interlok femoral component, catalog #: 183108, lot #: 967260, arcom series-a standard patella, catalog #: 184764, lot #: 494670, unknown palacos bone cement, catalog #: unknown, lot #: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-02353, 0001825034-2018-02354.

Event Description

It was reported that the patient was revised to address component loosening and pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of returned tibial tray and femur identified little to no cement fixation on the posterior side of the implants.The patellar component also shows no signs of cement fixation and one of the pegs appears to have been cut off.The peg was likely cut off during explanation.The tibial bearing has some small nicks and gouges on the superior surface.Dhr was reviewed and no discrepancies were found.A definitive root cause of the loosening cannot be determined.The products were likely conforming when they were released from zimmer biomet control.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02353 - 3.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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: BIOMET CRUCIATE TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7397858
• MDR Text Key: 104405506
• Report Number: 0001825034-2018-02354
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK915132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 141235
• Device Lot Number: J3687182
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 03/30/2018; 03/30/2018; 10/16/2018
• Supplement Dates FDA Received: 04/25/2018; 04/27/2018; 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR