MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED PARTIAL TIBIAL COMPONENT SIZE H; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported that the patient had a tibial plateau fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through review of radiographs.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A radiographic review was performed and confirmed evidence of tibial bone fracture.The review additionally indicated that post-operative images demonstrate an appropriate fit and alignment of the implants as well as adequate bone quality.No signs of component loosening or radiolucency were identified.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical devices: persona partial knee vivacit-e highly crosslinked polyethylene partial articular surface 8mm size h catalog #: 42518200808, lot #: 63442398, persona partial knee cemented partial femoral component size 4 catalog #: 42558000401, lot #: 63717684.

Event Description

It was further reported that the patient underwent initial left knee arthroplasty and subsequently experienced a displaced tibial plateau fracture thirteen (13) days post-operatively.The patient did not receive any treatment for the fracture, but was advised to not be weight-bearing while the fracture healed.

Event Description

It was reported that the patient experienced a displaced tibial plateau fracture thirteen (13) days following left knee arthroplasty.The patient was initially advised to not bear weight on the leg while the fracture healed, however, the patient eventually required an open reduction and internal fixation (orif) of the proximal tibia nine (9) weeks later to treat the fracture.Operative notes from the orif procedure noted that the fracture had somewhat healed in a varus malunited position and had to be broken free.Once the fracture was mobilized, the knee was reduced, alignment restored to place the fracture fragments into the correct position and screws were placed to stabilize the bone.

Manufacturer Narrative

Additional medical records were received and reviewed, however, the root cause remains unchanged with the information provided.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

No further event information available at the time of this report.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED PARTIAL TIBIAL COMPONENT SIZE H
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7380814
• MDR Text Key: 104029350
• Report Number: 0001825034-2018-02256
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2021

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 Model Number: N/A
• Device Catalogue Number: 42538000801
• Device Lot Number: 63696358
• Other Device ID Number: (01) 00880304812741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 05/09/2018; 05/09/2018; 03/31/2021; 04/28/2021
• Supplement Dates FDA Received: 04/17/2018; 05/09/2018; 05/09/2018; 04/26/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 136