MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CPS VE ART SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pain (1994)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: the 42532007101, persona stemmed 5-degree tibia, 62753686.The 42500606401, persona ps standard femoral, 62763523.The 00598901215, provisional for stem extension, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02996, 0001822565-2018-02995.

Event Description

It was reported that patient underwent a revision procedure approximately four years post-implantation due to pain and stiffness.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.X-rays reviewed by a radiologist demonstrates slight valgus positioning of the tibial component with tibial component angle of 92°.Adequate cement mantle.Tibiofemoral axis angle is 190° corresponding to overall valgus positioning of the knee.No acute fracture is seen.Evaluation of hardware alignment is limited given patient obliquity.There is radiolucency along the bone cement interface of the anterior and posterior tibial component which could suggest early loosening.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

• Brand Name: PERSONA CPS VE ART SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7568551
• MDR Text Key: 110043276
• Report Number: 0001822565-2018-02997
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 42512600718
• Device Lot Number: 63389469
• Other Device ID Number: (01) 00889024238114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 98