MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

Catalog Number 00584201402

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/13/2009

Event Type  Injury  

Event Description

It is reported that the patient was revised due to pain, and the knee "giving out".

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.A product history search for the tibial and femoral components found no add'l complaints against the part and lot combination.A search for the articular surface could not be performed due to the lack of product info.These devices are used for treatment of patients.A review of the primary surgical notes gave no indication of complications.A trial reduction w/the implants was performed and produced good stability.The surgeon reviewed one year post-operative x-rays and noted proper alignment of the prosthesis w/no evidence of loosening and detailed sclerosis & evidence of stress related changes to the tibial plateau of the medial compartment.The consumer mentions a premature revision to the knee, but no devices or photos were received; therefore the condition of the explanted components is unknown.Operative notes for the revision surgery have not been provided.Zimmer package insert states pain as a potential adverse effect of the surgical procedure.A definitive root cause cannot be determined with the info provided.

Manufacturer Narrative

This report is being amended to reflect changes.

• Brand Name: ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4944976
• MDR Text Key: 6040876
• Report Number: 1822565-2015-01317
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 00584201402
• Device Lot Number: 60647553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2007
• 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: LOT #UNK; ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE; CATALOG #00584200202; CATALOG #00584202209; LOT #60593852
• Patient Age: 51 YR