MAUDE Adverse Event Report: ZIMMER GMBH FITMORE HIP STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source switzerland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a hip revision due that fitmore stem became loose early.Attempts have been made and additional information on the reported event has not been provided at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The fitmore stem was returned without a femoral head to the post market surveillance team for examination.No significant bone on-growth is evident on the stem.There are scratches on the neck and on the taper of the stem, likely occurring during revision surgery and/or removal of the femoral head from the stem.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.With the available information, 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.

• Brand Name: FITMORE HIP STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18004700
• MDR Text Key: 326510110
• Report Number: 0009613350-2023-00565
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024591929
• UDI-Public: (01)00889024591929(17)300630(10)3035662
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K192236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0100551210
• Device Lot Number: 3035662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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
• Treatment: UNKNOWN HEAD.; UNKNOWN LINER.; UNKNOWN SHELL.
• Patient Outcome(s): Hospitalization; Required Intervention