MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS 2 PEGGED TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 42530007502

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 07/07/2015

Event Type  Injury  

Event Description

It is reported that the patient is experiencing pain and loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is now known that the patient underwent knee arthroplasty revision.

Manufacturer Narrative

The part and lot numbers are unk; therefore the device history records could not be reviewed.This device is used for treatment.Surgical notes were not provided.It is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the info provided.

Manufacturer Narrative

Concomitant medical products: item name: nexgen trabecular metal primary patella, item: 00587806538, lot: 62410797.Item name: nexgen trabecular metal cruciate retaining standard, item: 42502806802, lot: 62480234.Item name: nexgen articular surface cr right 12 mm, item: 42522000512, lot: 62342605.Device evaluation summary: no devices or photos were received; therefore the condition of the devices is unknown.The device history records for the tibial component were reviewed with no deviations or anomalies identified.This device is used for treatment.The reported components were reviewed for compatibility with no issues noted.Primary operative notes indicate that the patient underwent right total knee arthroplasty (tka) due to chronic knee pain and osteoarthritis.The implants were noted to provide adequate stability and range of motion.The surgeon noted no intraoperative complications during the primary surgery.The operative notes from the revision surgery indicate that the patient had been in pain shortly after the primary tka, and that the surgeon suspected the patient had tibial osteolysis with impending loosening.The tibial component, femoral component, and articular surface were removed during the revision surgery.The patellar component was not removed.The notes state that a quarter size area of osteolysis was identified when the tibial component was removed; there were no indications that the tibial component was loose.There were no issues noted with the femoral component, and no mention of excessive damage or wear of the articular surface that may have contributed to the osteolysis.A definitive root cause cannot be determined with the information provided.

Event Description

The patient was revised for osteolysis and pain.

• Brand Name: PERSONA POROUS 2 PEGGED TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 4840212
• MDR Text Key: 5870911
• Report Number: 1822565-2015-00890
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 42530007502
• Device Lot Number: 62268147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/23/2015; 09/01/2016; 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91