MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D6a implanted date: (b)(6) 2006.D10: cat# unknown lot# unknown ¿ unknown durom cup, cat# unknown lot# unknown ¿ unknown stem.Product remains implanted and 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.

Event Description

It was reported that approximately 18 years post implantation of a total hip arthroplasty, the patient is scheduled for a revision surgery to remove and replace the cup.It was reported that the patient's cobalt and chromium levels are elevated, and the patient has various metallosis issues.A recent mri was reported to also show significant fluid accumulation around the implant.No additional information available.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350 winterthur.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;b5;g3;h2;h3.The following sections were corrected: h10.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01035.0001825034-2024-01037.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350 winterthur.

• Brand Name: UNKNOWN HEAD
• 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: 19122275
• MDR Text Key: 340337333
• Report Number: 0001825034-2024-01036
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female