MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MLRY-HD POR FMRL 9X150MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problem Metal Related Pathology (4530)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown- unknown biomet magnum cup, size 50mm-unknown.Unknown-unknown 44mm mallory head-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02486, 0001825034 - 2022 - 02487.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a right hip revision approximately 10 years post implantation due to concerns of metallosis.During revision, a fair amount of metal-stained fibrous debris in the anterior aspect of the capsule was encountered as well as mild oxidation on the trunnion.The femoral head and neck were replaced with a biolox delta hip system without complications and the patient tolerated the procedure well.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04), stem.Reported event was confirmed, via medical records and radiographs reviewed by a health care professional.No product was returned or pictures provided.Visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies, during manufacturing.A definitive root cause cannot be determined.If any further information is found, which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 157444-m2a-magnum mod hd sz 44mm-771660.Us157850-m2a-magnum pf cup 50odx44id-920660.139256-m2a-magnum 42-50 tpr insrt std-507180.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

• Brand Name: MLRY-HD POR FMRL 9X150MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15735740
• MDR Text Key: 303087143
• Report Number: 0001825034-2022-02488
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-104109
• Device Lot Number: 379420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/10/2022; 12/09/2022
• Supplement Dates FDA Received: 12/06/2022; 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG