MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC/X POR NC LAT 17X165; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) d10: cat# us157856 lot# 010080 m2a-magnum pf cup 56odx50id, cat# 157450 lot# 189170 m2a-magnum mod hd sz 50mm, cat# 139252 lot# 884510 m2a-magnum 42-50mm tpr insrt-6.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00567, 0001825034-2024-00569, 0001825034-2024-00570.

Event Description

It was reported that approximately 14 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, and elevated metal ion levels.During the revision surgery, metal related pathology, joint effusion, and osteolysis were noted.The cup and head components were exchanged.There were no surgical complications.No additional information is available.

• Brand Name: BI-METRIC/X POR NC LAT 17X165
• Type of Device: PROTHESIS, 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: 18825004
• MDR Text Key: 336738277
• Report Number: 0001825034-2024-00568
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

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: 08/31/2012
• Device Model Number: N/A
• Device Catalogue Number: X11-180317
• Device Lot Number: 817370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2002
• 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