MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT 52/46 CODE L; DUROM ACETABULAR COMPONENT AND METASUL

Catalog Number 01.00214.052

Device Problem Failure to Align (2522)

Patient Problem Toxicity (2333)

Event Date 03/03/2015

Event Type  Injury  

Event Description

It was reported reported that the patient was implanted a durom acetabular component 52/46 code l on the left side on (b)(6) 2005.The patient was revised on (b)(6) 2015 due to misalignment and elevated metal ions metallosis.

Manufacturer Narrative

The manufacturer did not receive devices or x-rays for review.As not lot numbers were provided for the devices, the device history records could not be reviewed.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 form 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 (b)(4).Since the case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Zimmer's reference number of this file is (b)(4).

• Brand Name: DUROM ACETABULAR COMPONENT 52/46 CODE L
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 4615589
• MDR Text Key: 18921165
• Report Number: 9613350-2015-00329
• Device Sequence Number: 1
• Product Code: KWA
• 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: Physician
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 01.00214.052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 80