MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L FEMORAL STEM

Catalog Number 00771100700

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 10/30/2014

Event Type  Injury  

Event Description

It is reported the patient was revised due to femoral implant loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The product was not returned for evaluation so its exact condition cannot be described.The manufacturing documentation was reviewed and found conforming to zimmer quality procedures at the time of manufacture.No anomalies, ncrs, or deviations were associated with the dhr.Primary operative notes were reviewed and note excellent immediate press-fit stability upon inserting the actual femoral implant.Revision operative notes were reviewed and note formation of a distal pedestal, as well as a thick scar in the shoulder of the trochanter.Product compatibility was reviewed with no issues noted.With the information provided, a definitive root cause cannot be stated; however, it is not suspected that the device failed to meet specifications.

• Brand Name: ZIMMER M/L FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4877623
• MDR Text Key: 6258752
• Report Number: 1822565-2015-01000
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 00771100700
• Device Lot Number: 62169673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79