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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product remains implanted and will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00332; 0001822565-2024-00329; 0001822565-2024-00333.

Event Description

It was reported that the patient underwent a hip arthroplasty on an unknown date.Subsequently, the patient was being considered for a revision for an unknown reason; however, it was determined on an unknown date that the patient did not end up needing or having a revision.No additional information 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.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: right total hip arthroplasty with oversized acetabular cup and shallow acetabular inclination angle.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.Additionally, no problem was found with the devices upon further follow up.It was reported that the implant identification was not related to a revision and was just a follow up visit with a new patient.Additionally, the size and placement of the acetabular components are to the surgeon's discretion and does not indicate an implant issue.This complaint could not be confirmed.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: 18608570
• MDR Text Key: 334113551
• Report Number: 0001822565-2024-00335
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 01/17/2024
• 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