MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BLOCK AND SCREWS; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Concomitant medical products: tibia cemented; p/n: 00598003701, l/n: 63166116, stem extension; p/n: 00598801215, l/n: 63112619, tibial block and screws; p/n: 00598800326, l/n: 62917259, tibial block and screws; p/n: 00598800326, l/n: 62917259, articular surface; p/n: 00596203217, l/n: 62411647, all-poly patella cemented; p/n: 42540200032, l/n: 62235042, femur cemented; p/n: 42500006201, l/n: 62118568.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00568, 0002648920 - 2019 - 00569, 0001822565 - 2019 - 03303, 0001822565 - 2019 - 03304, 0001822565 - 2019 - 03305, 0002648920 - 2019 - 00570, 3007963827 - 2019 - 00225.

Event Description

It was reported patient had a second revision procedure 3 years post implantation due to pain, tibial loosening, instability, and patellar fracture.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was confirmed by review of medical records.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: periprosthetic lucency surrounding the tibial hardware component is consistent with loosening.This is further characterized by the abnormal orientation of the tibial stem.Also noted is a fracture to the superior pole of the patella and proximal migration.Moderate prepatellar soft tissue swelling is noted.Also, medical records were provided and reviewed by a health care professional.A review of the available records identified the following: review of the provided ops notes states no complication during the initial surgery.The patient was revised due to tibial loosening and pain.During this 1st revision surgery, the surgeon confirms that the femur and patella remain intact and tibia cannot be removed easily.The patient underwent 2nd revision surgery for loosening and migration of tibia component and periprosthetic patella fracture.During this revision surgery, the surgeon notes that the patient develops significant varus deformity with the obvious change in position of the tibial baseplate and fracture of the superior pole of the patella.The patella was not revised as the surgeon noted the fracture line on the patella bone was found to be superior enough that there was still full support for the patellar button and was still well fixed.During this surgery, the surgeon noted that he did not cut the bone-deep enough prior to trialing, so when he attempted to place the final implant, they would not seat.Prior to re-cutting, the surgeon noted a bone fracture in the anterior medial aspect of the femur.A cerclage cable was placed for fracture stabilization after the final implants were placed.Dhr was reviewed and no discrepancies were found.Per package insert: pain, swelling, instability, loosening of implants, malposition and bone fracture are known adverse effects of this procedure.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.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIAL BLOCK AND SCREWS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8860657
• MDR Text Key: 153261563
• Report Number: 0001822565-2019-03304
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598800326
• Device Lot Number: 62917259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2019
• 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: 64 YR
• Patient Weight: 142