MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN HEAD; HIP PROSTHESIS

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problem Pain (1994)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported that approximately thirteen years post initial implantation, the patient underwent a left sided hip revision due to pain and elevated metal ions.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2 - foreign: italy.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00526.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product details unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.However, the legal claim received reference to a high level of ion metal: - plasma cobalt values: 30.63 g/l.- serum chromium values: 58.96 g/l.With the available information, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Multiple supplemental mdr reports were filed for this event, please see associated reports: 0009613350-2023-00526-1.

Event Description

It was reported that approximately thirteen years post initial implantation, the patient underwent a left sided hip revision due to pain and elevated metal ions.Diligence was completed, no additional information was provided.

• Brand Name: UNKNOWN HEAD
• 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: 17797957
• MDR Text Key: 324022010
• Report Number: 0009613350-2023-00525
• Device Sequence Number: 1
• Product Code: KXA
• 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: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2023
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female