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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Cognitive Changes (2551); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D9: implant date 2011.D10: cat# unknown lot# unknown - unknown stem.Cat# unknown lot# unknown - unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00135; 0001822565-2024-00136.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.

Event Description

It was reported that the patient underwent a hip arthroplasty approximately twelve years ago.Subsequently, the patient is being considered for a revision on an unknown date for cobalt in the bloodstream causing cognitive decline.Though requested, no additional information was available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue cannot be confirmed; however, it was determined that the cup was likely unrelated to the reported issue.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.

• Brand Name: UNKNOWN CUP
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18487234
• MDR Text Key: 332578937
• Report Number: 0001822565-2024-00140
• Device Sequence Number: 1
• Product Code: LZO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/16/2024
• 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): Other
• Patient Sex: Male