MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 40 3 PEG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Scar Tissue (2060); Patient Problem/Medical Problem (2688)

Event Date 02/05/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right tka.The patient underwent revision of the patellar implant after fracturing his patellar bone during unspecified strenuous physical activity approximately 11 months post implantation.During the revision, the patellar bone fragment was revised and the loosened patella was replaced.A new patellar implant was fixed to the large patellar bone fragment that remained intact.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right patellar fracture post total knee arthroplasty, loosened patellar implant.Procedure: revision right patellar button with partial patellectomy.Patient reported an onset of pain in his knee during a period of time where was being very physically active, x-ray demonstrated a vertical longitudinal fracture of the patella (bone) at the junction of the middle and lateral 3rd.He has an extremely large patella, and the patellar button only covered a portion of it, even though it was the largest size available.Dense scar tissue excised.The (bone) fracture was over a portion of the button, which had some deformity to it(implant), and therefore needed to be revised.Fractured lateral bone fragment excised, loose patellar implant removed, new patellar implant applied to the intact patellar bone fragment.Images not being sent to mmi at this time.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.

• Brand Name: SERIES A PAT STD 40 3 PEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11272494
• MDR Text Key: 230045945
• Report Number: 0001825034-2021-00333
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K040770
• 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: 04/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: N/A
• Device Catalogue Number: 184770
• Device Lot Number: 981600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/09/2021
• 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
• Patient Weight: 127