MAUDE Adverse Event Report: ZIMMER PERSONA CEMENTED STEMMED TIBIAL PLATE

Catalog Number 42532007501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to loosening.

Manufacturer Narrative

Operative notes were not provided. Radiographs were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided. Device history records were reviewed and found conforming. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the available information, the need for corrective action is not indicated.

Manufacturer Narrative

Device history records were reviewed and no deviations or anomalies were found. These devices are used for treatment. Updated information received via operative notes. Primary operative notes indicate trial reduction revealed excellent alignment, stability, and range of motion from 0 to 120 degrees. Final components were implanted with cement under pressurization technique. Primary operative notes do not indicate root cause. X-ray report dated (b)(6) 2014 indicates that the components had satisfactory alignment and fixation. X-ray report dated (b)(6) 2014 indicates there is a concern for tibial loosening and femoral loosening behind the anterior range. Lab results taken (b)(6) 2014 2014 indicate patient tested negative for infection with normal hemoglobin levels. Revision operative notes indicate the femoral component was found to be loosening due to what appeared to be osteolytic changes. The tibial component was found to be completely loose and the articular surface was severely pitted. The femoral and tibial components were explanted with minimal bone loss. A product history search revealed no additional complaints against the related part and lot combinations. A definitive root cause cannot be determined with the information provided.

• Brand Name: PERSONA CEMENTED STEMMED TIBIAL PLATE
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4425614
• MDR Text Key: 12758541
• Report Number: 2648920-2015-00010
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 42532007501
• Device Lot Number: 62268896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/14/2015 Patient Sequence Number: 1