MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that during the surgery, the staff opened the implant and found hair on the poly.There are no known consequences or impact to the patient.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Visual evaluation of the provided photo found the packaging was previously opened.A hair-like fiber was found on the implant.As the product was previously opened, this complaint cannot be confirmed as the source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was previously opened.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found the packaging was previously opened.A hair-like fiber was found on the device.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.Return of the product does not alter the previous investigation as the root cause remains undetermined.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 further information at the time of this report.

• Brand Name: VIVACIT-E DM BEARING 28X44MM
• Type of Device: PROSTHESIS, 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: 18455573
• MDR Text Key: 332272218
• Report Number: 0001822565-2024-00074
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031012
• Device Lot Number: 66178872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2023
• 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