MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA UNI MED TIB; KNEE, PROSTHESIS

Catalog Number 42538000602

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04361, 0001822565-2018-04363, 0001822565-2018-04362.(b)(4).Concomitant medical products: palacos bone cement, cat: 66017747, lot: 85424559; psn pk cmt fem rm sz 5, cat: 42-5580-005-02, lot: 63449781; psn pk ve ply rm sz f 9mm, cat: 42-5282-006-09, lot: 63449781.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product not returned.

Event Description

It was reported that the patient underwent a revision of a partial knee prosthesis due to tibial fracture and loosening of the tibial component.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event as the patient was noted to have poor bone quality prior to the initial procedure and it was anticipated the patient would progress from a partial to a total knee replacement.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 UNI MED TIB
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7781168
• MDR Text Key: 117130664
• Report Number: 0001822565-2018-04361
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42538000602
• Device Lot Number: 63528244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR