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

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Udi: (b)(4).Medical products: biomet cc cruciate tray; p/n: 141231, l/n: j3884994, e1 vngd crl tib brg; p/n: ep-183522, l/n: 141070, vanguard cr ilok fem-lt; p/n: 183028, l/n: j6077425.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: 000180001825034-2019-04445.Product location is unknown.

Event Description

It was reported the patient had a revision procedure 2 years post-implantation due to due to pain, difficulty ambulating, having to use a walker, instability, and subsidence.Subsequently, loosening of the components lead to valgus alignment.The polyethylene bearing, femoral component and tibial tray was removed and replaced.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Medical products - unknown single peg patella unknown palacos gentamicin cement reported event was confirmed by review of surgery notes.Revision surgery notes state that the patient was revised due to tibial loosening and tibial subsidence.Abnormal edema was noted in the tissues, fluid yellow and clear and bone quality was quite severe and osteoporotic in this patient.Office visit notes states that patient had medial left knee pain, difficult to walk, uses a walker, does have occasional giving way in both for legs she feels from her back, recovered from spine surgery (compression fracture), left knee is bowlegged and painful with walking, full extension, flexion to 120 degrees, varus alignment.There was abnormal uptake on the medial tibial plateau and femoral components consistent with loosening and subsidence causing the knee into varus.Dhr was reviewed and no discrepancies 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: BIOMET CC CRUCIATE TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9151756
• MDR Text Key: 167601647
• Report Number: 0001825034-2019-04386
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K142933
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 141231
• Device Lot Number: J3884994
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• 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: 65 YR
• Patient Weight: 80