MAUDE Adverse Event Report: ZIMMER GMBH HIP STEM GENERIC; HIP STEM PRODUCT

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 06/01/2013

Event Type  Other  

Event Description

A product liability claim was raised.It was reported that the patient was implanted a hip system product on the left side on (b)(6) 2007.On (b)(6) 2013 "following radiographic testing for episodes of pain in left hip, an abnormal fracture of the implanted titanium stem prosthesis was detected".To date, the patient has not been revised.

Manufacturer Narrative

The manufacturer did not receive device, x-rays or other source documents for review as the patient has not been revised.As no lot number was provided for the device, 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, the changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Continued - still implanted.

• Brand Name: HIP STEM GENERIC
• Type of Device: HIP STEM PRODUCT
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 57426761
• MDR Report Key: 4173770
• MDR Text Key: 5103239
• Report Number: 9613350-2014-03983
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 59 YR