MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SMITH RT HA TRIFLANGE SZ25; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient has been indicated for revision due to bone loss, erosion, component migration, and loosening.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

Review of the device history records identified no deviations or anomalies during manufacturing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A definitive root cause could not 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.

Event Description

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

• Brand Name: SMITH RT HA TRIFLANGE SZ25
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12507151
• MDR Text Key: 272508529
• Report Number: 0001825034-2021-02689
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/16/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: PM156092
• Device Lot Number: 487750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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