MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PETELLA STANDARD CEMENTED SIZE 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem Pain (1994)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee surgery and approximately 12 years later presented complaining of pain and the surgeon suspected loosening.However, no loosening was seen on x-ray and no loosening was confirmed during surgery.The surgeon decided to remove the synovium to mitigate the pain.He also found damage and wear on the explanted patella and articular surface such as a gouge to the patella and scratches on the poly.Both of these components were replaced.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 00596202210 - articular surface use with lps/lps-flex 51 or 52 suffix femorals size cd 10 mm height - 61786153.Unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.G2 : foreign country : japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03698.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under: 0002648920-2024-00119.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: ALL POLY PETELLA STANDARD CEMENTED SIZE 29 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18364412
• MDR Text Key: 330996048
• Report Number: 0001822565-2023-03697
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 10/15/2019
• Device Model Number: N/A
• Device Catalogue Number: 00597206529
• Device Lot Number: 61905923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2011
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 51 KG