MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN METAL ON METAL IMPLANT

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/16/2008

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial left mom hip surgery.Approximately nine years post-implantation follow up examinations allegedly resulted in elevated metal ion levels.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Report source: foreign - italy.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).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.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.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

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the product is not winterthur design control.This event has been reported by medwatch facility biomet uk ltd.Given this information this medwatch will be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the product is not winterthur design control.This event will been reported by medwatch facility biomet uk ltd - 3002806535.Given this information this medwatch will be voided.

• Brand Name: UNKNOWN METAL ON METAL IMPLANT
• Type of Device: UNKNOWN
• 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: 14839764
• MDR Text Key: 295041049
• Report Number: 0009613350-2022-00347
• Device Sequence Number: 1
• Product Code: MRA
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/12/2022
• Supplement Dates FDA Received: 09/12/2022; 04/28/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male