MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Code Available (3191)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - stem extension 00598801011, lot 62255361, tibial component 00588000300, lot 62209202, stem extension 0598801010, lot 61894690, femoral component 00588001401, lot 61885066, tibial block 00598800326, lot 61988733, tibial block 00598800426, lot 62290267.(b)(6.The complaint of revision due to pain from pseudo-tumor can be confirmed from x-ray review.However, complaint of corrosion/oxidation on the implants cannot be confirmed as neither excessive wear nor corrosion were seen on the returned devices.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause for this event cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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

It is reported that the patient's knee arthroplasty was revised due to pain and a pseudo tumor along the resected tibial plane that created a hole through the cortical bone.Black color was also noticed around the device.

Manufacturer Narrative

(b)(4).

• Brand Name: NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7207168
• MDR Text Key: 97800595
• Report Number: 0001822565-2017-03522
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00588001401
• Device Lot Number: 61885066
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR