MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS 135 SIZE 18; WAGNER CONE PROSTHESIS SYSTEM

Catalog Number 01.00561.318

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Fluid Discharge (2686)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported that the patient was implanted a wagner cone stem 135 size 18 on the right side on (b)(6) 2010.It was reported that the patient complained of chronic hip pain since implantation.Revision surgery was performed on 09/30/2014.During procedure, large amounts of "thick grey fluid" were discovered with metal debris on stem trunnion and femoral head.The femoral stem was not removed, however the trunnion was cleaned.

Manufacturer Narrative

The manufacturer did not receive the device for investigation since it is still implanted.No surgical report or x-rays were provided for review.A lot number was received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the info provided.As soon as additional info become available and an investigation result will be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Note: this is a split case with zimmer warsaw for the head and liner, reference number (b)(4).

• Brand Name: WAGNER CONE PROSTHESIS 135 SIZE 18
• Type of Device: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4227908
• MDR Text Key: 21315977
• Report Number: 9613350-2014-04071
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2014

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: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 01.00561.318
• Device Lot Number: 2566765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 79