MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING; PROSTHESIS KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem Joint Laxity (4526)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: femur cemented cruciate retaining (cr) narrow right size 6 catalog # 42502006002 lot # 64694425.All-poly patella cemented 32 mm diameter catalog # 42540200032 lot # 64776022.Articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 6-7 catalog # 42522100411 lot # 64477748.Tenet knee 2-primary w/ve catalog # 98000630100 lot # unknown.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.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced tibial loosening and migration of the implant several months later.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates that 3 month post-operative images demonstrate lucencies along the anterior, posterior and medial tibial tray that may be associated with clinical loosening.Overall fit and alignment are maintained on the initial images with development of lucencies along the tibial implant.Bone quality appears to be osteopenic.No migration or change in implant position is noted.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 NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739284
• MDR Text Key: 247788855
• Report Number: 0001822565-2021-01163
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K173417
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: 42530006702
• Device Lot Number: 64804226
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Weight: 82