MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS TWO PEG TIBIAL COMPONENT; OIY

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient has a subsided tibial component.The surgeon indicated that the patient's pain is improving and they will not proceed with revision surgery at this time.

Manufacturer Narrative

No product was returned as it is still implanted; visual and dimensional evaluations could not be performed.The device history records were reviewed with no deviations/ anomalies identified.This device is used for treatment.A product history search identified no other complaint for the part and lot combination of the tibial component.Surgical notes were not provided; it is unknown whether the component was implanted with the correct fit and orientation as per the surgical technique.A field action was conducted on february 19, 2015 in which zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The device in question was implanted prior to this field action.Fda recall z-1266-2015 contains the related tibial lot number.A corrective and preventive action investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.

Manufacturer Narrative

A product history search identified no other complaints for the part and lot combination of the tibial component.Office visit notes from (b)(6) 2016 state that the patient was experiencing intermittent abrupt onsets of pain after walking.The notes indicate the x-rays show a slight increased uptake on the tibial base plate that could be physiologic but do not completely rule out loosening.Office visit notes from (b)(6) 2016 state that the previously mentioned potential subsidence does not appear to be subsidence at this point but looks more like bony ingrowth.Lucency along the lateral aspects of the implant were also noted.Primary operative notes confirm the patient underwent right total knee arthroplasty due to osteoarthritis.The knee was noted to have symmetrical and equal balance during trialing and the knee could be brought out to full extension.No complications were noted.This information does not change the findings of the previous investigation.

• Brand Name: PERSONA POROUS TWO PEG TIBIAL COMPONENT
• Type of Device: OIY
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5385035
• MDR Text Key: 36624369
• Report Number: 1822565-2016-00128
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2015

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530008302
• Device Lot Number: 62500407
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2016; 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2013
• 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): Other
• Patient Weight: 107