MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN FEMORAL COMPONENT POROUS RIGHT SIZE F; PROSTHESIS, KNEE

Catalog Number 00595201602

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 01/30/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: nexgen porous stemmed tibial plate size 6, item # 00598204702, lot # 54071300.Nexgen articular surface size green/c-h 14mm, item # 90597004014, lot # 56268800.Nexgen all poly patella size 35mm, item # 00597206535, lot # 60107540.Self-tapping bone screw 6.5mm, item # 00511007030, lot # 25005800.Self-tapping bone screw 6.5mm, item # 00511007040, lot # 20132000.Self-tapping bone screw 6.5mm, item # 00511007040, lot # 20131900.Self-tapping bone screw 6.5mm, item # 00511007040, lot # 21093200.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the location of the device is unknown.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: 0001822565-2017-04597, 0001822565-2017-04598, 0002648920-2017-00433, 0002648920-2017-00434, 0002648920-2017-00435, 0002648920-2017-00436, 0002648920-2017-00437.

Event Description

It was reported following an initial knee arthroplasty, the patient was revised due to loosening.The patient was experiencing pain.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was confirmed by review of op notes.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

Revision operation notes state that patient was revised on right knee due to pain, aseptic loosening of the knee components and possible infection.It was noted that the bone behind the femur was quite soft and femoral component appeared to be loose and came off quite easily.The tibial component came off quite easily as well with minimal bone loss.Patella was also removed.Later new implants were implanted which includes antibiotic spacer.

• Brand Name: NEXGEN FEMORAL COMPONENT POROUS RIGHT SIZE F
• 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: 6689844
• MDR Text Key: 79177328
• Report Number: 0001822565-2017-04595
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

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: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 00595201602
• Device Lot Number: 60099853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR