MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN ZIMTRON HEAD; IOI BIPOLAR PROSTHESIS

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported in a medical journal that 13 patients received an unknown zimtron head.According to the article, one of the patients is being monitored due to aseptic loosening after less than five years from implantation.Endosteal cavitation was also observed.Details of patients and implant date are unknown.

Manufacturer Narrative

The reported product was not manufactured by zimmer (b)(4).Therefore this case will be invalidated.(b)(4).

• Brand Name: UNKNOWN ZIMTRON HEAD
• Type of Device: IOI BIPOLAR PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5103731
• MDR Text Key: 26734303
• Report Number: 9613350-2015-01331
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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): Other