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

Catalog Number 01.00214.048

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign: italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent an implantation of acetabulum prosthesis approximately seventeen (17) years ago.Approximately fourteen (14) years post implantation, the patient had developed metallosis, pseudotumor and an unspecified infection.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.No product was returned for visual examination.No evaluation of the pictures/x-rays as the reported event is already known and addressed.According to the received surgical reports, the reported event can be confirmed.This device is intended for treatment.A review of the device history records did not identify any deviations or anomalies during manufacturing.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.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.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 ACETABULUM, UNCEMENTED, 48/ø 42, CODE H
• 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: 17097987
• MDR Text Key: 316863564
• Report Number: 0009613350-2023-00263
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024422940
• UDI-Public: (01)00889024422940(17)110131(10)2309172
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Catalogue Number: 01.00214.048
• Device Lot Number: 2309172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2005
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Prefer Not To Disclose