MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM COMPONENT FOR ACETABULUM, UNCEMENTED, 58/ 52, CODE R; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Osseointegration Problem (3003); Migration (4003)

Patient Problem Pain (1994)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical products: fitmore, hip stem, uncemented, b/5, taper 12/14; catalog#: 01.00551.205; lot#: 2483373; metasul ldh, head, 52, code r, taper 18/20; catalog#: 01.00181.520; lot#: 2395808; metasul ldh, head adapter, m, 0, taper 12/14-18/20; catalog#: 01.00185.146; lot#: 2492867.Therapy date: (b)(6) 2019.The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted with a durom cup on the right side and underwent a revision surgery due elevated metal ions, migration, pain, limited range of motion and osteolysis.

• Brand Name: METASUL DUROM COMPONENT FOR ACETABULUM, UNCEMENTED, 58/ 52, CODE R
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 11617895
• MDR Text Key: 243918600
• Report Number: 0009613350-2021-00163
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.058
• Device Lot Number: 2413111
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2007
• 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; Required Intervention