MAUDE Adverse Event Report: ZIMMER GMBH DUROM CUP HIP; N/A

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Reaction (2414)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medical products and therapy date detail of product.Item number unknown; item name metasul head hip.Lot # unknown.Item number unknown; item name metasul head adapter hip.Lot # unknown.Item number unknown; item name stem hip impl win.Lot # unknown.The manufacturer did not receive devices or x-rays for review.As no 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 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.No further investigation required as this issue is known and addressed in (b)(4) (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Therefore, zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

A patient is pursuing a product liability claim because he underwent revision surgery due to elevated metal ion levels and metallosis.

• Brand Name: DUROM CUP HIP
• Type of Device: N/A
• 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: 9813292
• MDR Text Key: 193064493
• Report Number: 0009613350-2020-00104
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2020
• 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