MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/A 48, CODE N; N/A

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/02/2010

Event Type  Injury  

Manufacturer Narrative

Medical products and therapy date detail of product: item number 0100181480.Item name metasul ldh, head, 48, code n, taper 18/20 lot # 2482055.Item number 0100295013.Item name cls spotornoâ®, stem, 125, uncemented, 13.75, taper 12/14 lot # 2453048.Item number 0100185148.Item name metasul ldh, head adapter, xl, +8, taper 12/14-18/20 lot # 2322690.The manufacturer did not receive x-rays, or other source documents for review.The device has not been received for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.A cause for this specific clinical event cannot be ascertained from the information provided.A product failure cannot be confirmed.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, an amended medical device report will be filed.A tight monitoring is ongoing for revisions with outside us durom cups where the initial implant date occurred after the accomplishment of a retraining program for users outside the usa which was initiated in november 2009 as a corrective action 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).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.The need for further corrective measures is not indicated at this time and zimmer gmbh considers this case as closed.The need for corrective measures is not indicated and zimmer gmbh 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 experienced pain, reduced mobility and elevated metal ions.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/A 48, CODE N
• 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: 9675246
• MDR Text Key: 177959482
• Report Number: 0009613350-2020-00055
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.054
• Device Lot Number: 2469262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2008
• 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): Other