MAUDE Adverse Event Report: ZIMMER, INC. NATURAL KNEES II SYSTEM POROUS FEMORAL COMPONENT; KNEE PROSTHESIS

Catalog Number 621200041

Device Problems Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 08/03/2011

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to pain, wear, and osteolysis.

Manufacturer Narrative

Concomitant medical product(s): 620009909 prim.Congr.Insert 3,4,5/r 9 1474931; 621201240 prim.Stem.Tibia basepl.4/r pc 1478786; 621200041 primary femoral 4/r pc 1476849; 620001103 kne-nk2-imp-pat 1484805; 430107050 6.5mm bone screw, 50mm length unknown.Complaint sample was evaluated and the reported event was confirmed.As received all components exhibit signs of being implanted.Poly components exhibit wear.The tibia, patella, and femoral have foreign material in porous coating and scratched.There is too much damage to take any dimensions.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required definitive root causes for ¿osteolysis¿, ¿wear¿, and/or ¿pain¿ cannot be determined from the available limited information.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 was reported by patient's counsel that the patient received a knee implant.Subsequently the patient was revised.Patient alleges through counsel that excess plastic wear debris was generated by the implant and funneled down through the screw holes of the baseplate of the implant and into the patient's tibia.Patient's counsel further alleges that the wear debris inside the bone triggered an autoimmune response and in the process of cleaning up the foreign plastic particles, the patient's immune system ate away the bone tissue from the inside out.

• Brand Name: NATURAL KNEES II SYSTEM POROUS FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 5997409
• MDR Text Key: 56390896
• Report Number: 0001822565-2016-03520
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK936159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

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 Catalogue Number: 621200041
• Device Lot Number: 1476849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2015
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR