MAUDE Adverse Event Report: ZIMMER GMBH METASUL LDH, HEAD, 46, CODE L, TAPER 18/20; N/A

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Reaction (2414)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Medical products and therapy date detail of product: item number 0100214052, item name metasul durom, component for acetabulum, uncemented, 52¸ 46, code l lot # 2267929.Item number 0100185146, item name metasul ldh, head adapter, m, 0, taper 12/14- 18/20, lot # 2291567.Item number 290039080, item name cls spotorno, stem, 135, uncemented, 8.0, taper 12/14, lot # 2278300.The manufacturer did not receive devices or x-rays 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.No further investigation required as this issue is known and addressed in cp00000620 (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.Should any additional information that changes the assessment become available to us, since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Therefore, zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that patient underwent revision surgery due to periprosthetic infection, osteolysis and elevated metal ions.

• Brand Name: METASUL LDH, HEAD, 46, CODE L, TAPER 18/20
• 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: 9283672
• MDR Text Key: 165262855
• Report Number: 0009613350-2019-00656
• Device Sequence Number: 1
• Product Code: KWY
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2010
• Device Model Number: N/A
• Device Catalogue Number: 01.00181.460
• Device Lot Number: 2276764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2005
• 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: 47 YR