MAUDE Adverse Event Report: ZIMMER GMBH DYNARDI IMPLANT GENERIC; UNKNOWN

Device Problem Metal Shedding Debris (1804)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 01/20/2015

Event Type  Other  

Event Description

It was reported, that a dynardi implant generic was implanted on (b)(6) 2008.Since few years the patient has been complaining about different symptoms.It was found that the patient has a high concentration of nickel in the blood.

Manufacturer Narrative

The manufacturer did not receive devices or x-rays 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).

• Brand Name: DYNARDI IMPLANT GENERIC
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 57426761
• MDR Report Key: 4544363
• MDR Text Key: 5356280
• Report Number: 9613350-2015-00248
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR