MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 42/H; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number 01.00211.142

Device Problem Biocompatibility (2886)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 07/18/2014

Event Type  Injury  

Event Description

It was reported that approximately seven years after initial implantation, the patient underwent a revision due to impeded range of motion and elevated metal ion levels.During revision, extensive metallosis with a large pseudotumor and tissue damage was noted.The bone defects resulted in a fracture fragment of the greater trochanter during acetabular preparation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - medical devices: metasul durom, component for acetabulum, uncemented, 48/ 42, code h; item# 01.00214.048; lot# 2390568 g2 - foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00410 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned for visual examination.Review of the device history records did not identify any deviations or anomalies during manufacturing.This device is intended for treatment.No evaluation of the pictures/x-rays as the reported event is already known and addressed in a previous capa.According to the received surgical reports, the reported event can be confirmed.No further investigation required as this issue is known and addressed in capa (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).Most likely root cause for the reported event is inappropriate use/implantation of the product.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 42/H
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• 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: 17378790
• MDR Text Key: 319653098
• Report Number: 0009613350-2023-00409
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 00889024422827
• UDI-Public: (01)00889024422827(17)090915(10)2233625
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2009
• Device Catalogue Number: 01.00211.142
• Device Lot Number: 2233625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2004
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White