MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 01/19/2011

Event Type  Injury  

Event Description

A product liability claim was raided.It was reported that the pt was implanted a winterthur generic hip on the right side on (b)(6) 2005.On (b)(6) 2010 an ultra sound test revealed that the pt had a bit of iliopsoas bursitis on the right side.The pt was revised on (b)(6) 2011 due to pain.

Manufacturer Narrative

The mfr did not receive devices, x-rays, or other source documents for review.As no lot number was provided for the device, the device history record could not be reviewed.Due to fact that this is a legal claim, our legal dept has been provided with the available facts from the customer.Zimmer (b)(4) legal dept is well trained and passes all info concerning the case to our complaint handling dept.As soon as supplemental info becomes available an updated report will be submitted.(b)(4).

Manufacturer Narrative

Additional information received on february 04, 2015.Since this case is related to the issues for which zimmer implemented a corrective action which was reported to the fda in july 2008 as correction z-2415/2426-2008, there will be no further investigation.

Event Description

It has now been reported that the patient was implanted durom acetabular component.The patient was revised due to pain, metallosis and bursitis.

Event Description

It has now been reported that the patient was implanted a durom acetabular component 48/42 code h.Left side case: (b)(4).

Manufacturer Narrative

This case was reopened on june 07, 2016 to enter additional information which had been received on may 17, 2016.Since this case is related to the issues for which zimmer implemented a corrective action which was reported to the fda in july 2008 as correction z-2415/2426-2008, there will be no further investigation and zimmer gmbh will close this case.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: DUROM ACETABULAR COMPONENT
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4340379
• MDR Text Key: 19313904
• Report Number: 9613350-2014-04197
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/01/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female