MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Reaction (2414)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: persona trabecular metal natural femur, catalog #: 42502806402, lot #: 62823801.Persona fixed bearing articular surface, catalog #: 42522000611, lot #: 62807459.Nexgen trabecular metal primary patella, catalog #: 00587806538, lot #: 62726902.Product will not be returned to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee procedure.Subsequently, the patient was revised due to tibial loosening and pain.The femur was revised because of concern of nickel metal energy.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Review of the x-rays by private hcp indicates that these pictures of x-rays are sub-optimal.The fit and alignment of the implants are appropriate.There is no sign of loosening on the ap film and the skyline views.No metal particles are visible.There is no indication as to why a revision was needed on these images.Overall, right total knee arthroplasty without definite lucency to suggest loosening or infection.Review of the dhr found no discrepancies relevant to the reported event.Per the package insert persona the personalized knee system, pain, loosening and metal sensitivity are known potential adverse effects of the tka procedure.Complaint history review identified that this device is in scope of a previously initiated recall due to this issue.The root cause is determined to be a previously addressed design issue.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 that a patient underwent an initial knee arthroplasty.Subsequently, the patient was revised due to tibial loosening and pain.The femur was revised because of concern of nickel metal allergy.

Manufacturer Narrative

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 further reported the patient almost nearly fell (slipped) and felt a pull approximately two months post-implantation.The patient stated that his thigh muscle felt strained with pain/bruising.Patient also noted to have mild pain when walking or using stairs.Operative notes received further indicated that approximately seven days prior to the revision procedure, the patient noted pain, stiffness, swelling and grinding.Further, walking/standing, using stairs, rising from a chair, and getting in and out of a car all caused increased pain.The patient was also noted to have a slight limp.During the revision procedure, the surgeon noted that the tibial component only had 50% bony ingrowth on the backside of the implant.

• Brand Name: PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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: 7153865
• MDR Text Key: 96010771
• Report Number: 0001822565-2017-08649
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• 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,Followup
• Report Date: 04/04/2018

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 Model Number: N/A
• Device Catalogue Number: 42530007902
• Device Lot Number: 62743335
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 02/21/2018; 03/07/2018
• Supplement Dates FDA Received: 02/27/2018; 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82