MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 56/V; DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 01/24/2005

Event Type  Injury  

Manufacturer Narrative

Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.Surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

A patient is pursuing a product liability claim.It was reported that the patient was implanted a durom - femoral component on the right side on (b)(6) 2004 and the patient underwent revision surgery on (b)(6) 2005 due to femoral component loosening.

Manufacturer Narrative

Additional information has been requested and is currently not available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: patient was implanted durom - femoral component on (b)(6) 2004.Subsequently, patient experienced femoral component loosening and exchanged to ldh - adaptor on (b)(6) 2005.Durom retained.Review of received data: surgical report : review of surgical report did not lead to new information regarding the reported event.Other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event.Conclusion: the patient had a durom cup implanted together with a durom femoral component.Based on the available data it can be hypothesized that the implantation technique and positioning of durom acetabular cup potentially had influence on the reported event(s).Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations.As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required.The durom cup reported in this case is not marketed in the usa.A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will reevaluate the case.Zimmer biomet considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 56/V
• Type of Device: DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6829650
• MDR Text Key: 83970619
• Report Number: 0009613350-2017-01156
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK070292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2008
• Device Model Number: N/A
• Device Catalogue Number: 01.00211.156
• Device Lot Number: 2154479
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2003
• 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; Required Intervention
• Patient Age: 50 YR