MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Concomitant medical products: item number 00588604310 lot number 62240022 trabecular metalâ¿¢ cruciate retaining monoblock tibial component: yellow, size 3 c-h, 10 mm\ item number 00597206526 lot number 62407083 inset all poly patella size 26 mm dia.Standard 7.5 mm thickness.Customer indicated that product will not be returning to zimmer biomet due to the inability to re-sterilize.Investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient fell in the kitchen and had a revision due to dislocation approximately 5 years after initial implantation.

Event Description

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

Manufacturer Narrative

The complaint was unable to be confirmed.Per the nexgen cr-flex and lps-flex gender solutions femoral components package insert dislocation is a known potential adverse effect of this procedure.The package insert also states that excessive physical activity and injury can result in loosening, wear, and/or fracture of the knee implant.Reported information states that the patient dislocation was subsequent to a fall; however, this could not be confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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: CRUCIATE RETAINING FEMORAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7833424
• MDR Text Key: 118784815
• Report Number: 0001822565-2018-04693
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK072619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00575201506
• Device Lot Number: 60889729
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• 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: 62 YR
• Patient Weight: 145