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

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).(b)(4).Concomitant medical products - unknown persona partial knee femur.Unknown persona partial knee bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the implant remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient felt a post-operative pain on her knee while walking and was diagnosed with anterior tibial implant peg fracture.The surgeon felt that the fracture line didn't extend to the posterior and that the pain will subside, no revision was scheduled so far.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.

Event Description

It was reported that the patient felt a post-operative pain on her knee while walking and was diagnosed with anterior tibial implant peg fracture.The surgeon felt that the fracture line didn't extend to the posterior and that the pain will subside, no revision was scheduled so far.It is now known that the event is for tibial bone fracture, rather than implant fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical devices - partial femur cemented # item 42558000301 lot 63659433; unknown persona partial knee bearing.Reported event was confirmed by review of x-rays.Review of x-rays indicates left medial knee compartment hemiarthroplasty with vertically oriented, minimally displaced fracture involving the medial tibia extending to the hardware.It was also noted that possible oblique linear lucency involving the anterior cortex of the proximal tibia extending to the hardware.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 the patient felt a post-operative pain on her knee while walking and was diagnosised with tibial bone fracture.The surgeon felt that the fracture line didn't extend to the posterior and that the pain will subside, no revision was scheduled so far.

• Brand Name: PERSONA PARTIAL TIBIAL CEMENTED
• 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: 7116534
• MDR Text Key: 94798794
• Report Number: 0001825034-2017-11121
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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: 42538000401
• Device Lot Number: 63607192
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR