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

Catalog Number 00771101320

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It is reported that the patient was revised due to a loose stem.

Manufacturer Narrative

Evaluation summary: x-rays were not provided; it is unknown whether the components were implants with the correct fit and orientation as per the surgical technique.Patient factors that may affect the performance of the components such as bone quality, type of activity (low impact vs.High impact) and relevant medical history are unknown.Surgical notes for primary operative procedure state that the femoral canal was broached sequentially with a broach that matched the patient's femoral anteversion.The femoral implant was inserted and immediate press-fit stability was obtained.All trial and final reductions revealed excellent range of motion, stability and restoration of leg lengths.Revision surgery notes indicate that a workup for infection was negative.Radiographs revealed a very small distal pedestal.Frozen sections revealed no evidence of acute inflammation.The surgeon stated that there was no evidence of gross motion.The extracted stem was evaluated by the surgeon and he stated that there was no bony ongrowth circumferentially on the femoral stem.A definitive root cause cannot be determined with the information provided.Device history records indicate all components were manufactured and inspected to specifications.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4641408
• MDR Text Key: 5600492
• Report Number: 1822565-2015-00418
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 00771101320
• Device Lot Number: 62386156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: 63 YR
• Patient Weight: 111