MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/ 42, CODE H

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Osteolysis (2377)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown head hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: (b)(6) 2020.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.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.(b)(4).

Event Description

A product liability claim was raised.Patient was implanted on the right side and underwent a revision surgery due to pain, elevated metal ion levels, metallosis and osteolysis.In 2018, the patient experienced pain and was advised for a revision of prosthesis due to danger of metallosis.The blood test actually produced significant results, so the patient felt difficulty in walking.Patient also fell down due to her unstable leg, also banging her head.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48/ 42, CODE H
• Type of Device: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED
• 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: 11064166
• MDR Text Key: 223361276
• Report Number: 0009613350-2020-00611
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 01.00214.048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2020
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR