MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT 46/40 F; DUROM ACETABULAR COMPONENT AND METASUL LDH

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Pain (1994); Fluid Discharge (2686); No Code Available (3191)

Event Type  No Answer Provided  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.The common clinical presentation and the date of the original implantation suggest that this case might be related to the issues for which zimmer implemented a notification in july 2008 as referenced above.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

A product liability claim was raised.It was reported that the patient was implanted a durom acetabular component on an unknown side (exact date not reported).Currently patient is being monitored due to unknown reasons.

Manufacturer Narrative

Additional information received on june 28, 2016.Since this case is related to the issues for which zimmer implemented a notification in july 2008, zimmer (b)(4) will close this case.(b)(4).

Event Description

It has now been reported that the patient was implanted a durom acetabular component 46/40 f on the left side on (b)(6) 2008.The patient was revised on (b)(6) 2016 due to pain, loosening, fluid collection and metallosis.

• Brand Name: DUROM ACETABULAR COMPONENT 46/40 F
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; 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 ; 8006136131
• MDR Report Key: 5681287
• MDR Text Key: 45959481
• Report Number: 0009613350-2016-00785
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.146
• Device Lot Number: 2410739
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention