MAUDE Adverse Event Report: ZIMMER, INC. PERSONA 2 PEG POROUS TIBNIAL COMPONENT

Catalog Number 42530006701

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/05/2015

Event Type  Injury  

Event Description

It is reported that the patient is experiencing pain and stiffness.It is also reported that the component slipped out of place.

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.Device history records were reviewed and no deviations or anomalies were found.This device is used for treatment.X-rays were not returned for review, but it was reported that "part of the component slipped out of place".A field action was conducted on (b)(6) 2015, in which zimmer voluntarily removed the personal trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.This field action has been reported to the fda under (b)(4).The device in question was implanted prior to this field action.Fda recall (b)(4), contains the related tibial lot number.The pkg insert states that "loosening of the prosthetic knee components" is an adverse effect.This is therefore, a known inherent risk of the procedure.A product history search revealed no add'l complaints against the related part and lot combination.Surgical notes were not provided; it is unknown whether the components were implanted wi/the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the info provided.

Manufacturer Narrative

Updated information received confirms that patient underwent revision surgery due to pain and possible loosening of the tibial component.No devices or photos were received; therefore the condition of the components is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.The capa investigation for fda recall z-1266-2015 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.

Event Description

It is now reported that the patient was revised due to pain and loosening.

Manufacturer Narrative

This report is being amended to reflect changes.Legal update received included primary operative notes, revision operative notes, and implant label stickers.Operative notes from the primary surgery indicate that the patient underwent a left total knee arthroplasty due to osteoarthritis of the left knee.Range of motion and stability were checked with trial components and were found to be excellent.Revision notes received confirmed that the tibial component had subsided anteriorly and the medial peg was grossly loose.The tibial component was removed and the new component was cemented in place.

• Brand Name: PERSONA 2 PEG POROUS TIBNIAL COMPONENT
• 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: 4934610
• MDR Text Key: 6016248
• Report Number: 1822565-2015-01272
• 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: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2015

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: 01/31/2024
• Device Catalogue Number: 42530006701
• Device Lot Number: 62522564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2015; 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 MO