MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA FEMORAL PROVISIONAL; PROVISIONAL, KNEE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will 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.Investigation incomplete.

Event Description

It is reported that the surgeon has suggested that performing knee arthroplasty according to the surgical technique requires the femoral box cut to be completed through the femoral trial, which tends to slightly flex the trial and may effect the cuts made.The surgeon has noted an increase in early revisions performed to address femoral loosening and suggested that the femoral trial may be contributing to these revisions.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.The dhr was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: UNKNOWN PERSONA FEMORAL PROVISIONAL
• Type of Device: PROVISIONAL, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11214917
• MDR Text Key: 228205927
• Report Number: 0001822565-2021-00213
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• 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