MAUDE Adverse Event Report: ZIMMER INC MILLER-GALANTE II ARTICULAR SURFACE; JWH

Catalog Number 00511005009

Device Problems Material Discolored (1170); Delamination (2904); Naturally Worn (2988)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to pain, swelling and polyethylene wear/debris.Only the articular surface was removed.

Manufacturer Narrative

The articular surface was returned for review.Visual inspection reveals severe delamination and discoloration centrally located where the femoral component would articulate on the poly, proximal surface.Delamination and discoloration is also observed on the distal surface.There is also some additional wear on the medial edge of the component.This wear likely resulted after the central articulating surface wore and tracking of the femoral component would have compensated for the wear.Dimensions were found conforming to print specifications where measured.Device history records were reviewed with no deviations or anomalies identified.The exact implantation date is unknown, but based on the manufacturing date (1991) and explant date (2015), the component could have been in situ from 15 to 24 years.This device is used for treatment.Primary operative notes were not returned for review.Revision operative notes confirm the patient underwent revision due to a thinned poly, previously confirmed with arthroscopy.Bone scans showed some increased uptake in both the femoral and tibial components, but these were found to be well fixed; therefore, only the articular surface exchange was performed.Inspection of the component revealed lamination and pitting and that it was so thin you could almost see the metal-backed tibial plate.The patellar component had some cold flow, but no pitting or delamination and therefore was not revised.Post-operative x-rays confirmed good anatomic alignment.A product history search revealed no additional complaints against the related part and lot combination.Based on the pattern of wear and the estimated in situ time, it is likely that the required revision of the articular surface was due to wear and tear from use.

• Brand Name: MILLER-GALANTE II ARTICULAR SURFACE
• Type of Device: JWH
• 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: 5550302
• MDR Text Key: 41965830
• Report Number: 1822565-2016-00886
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00511005009
• Device Lot Number: 77154200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/1991
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR