MAUDE Adverse Event Report: ZIMMER GMBH FITMORE®, SHELL WITH SCREW CONES, UNCEMENTED, 56/KK; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset item# 00771101200 lot# unknown.G2.Report source: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that severe osteoarthritis of the right hip with a healed fractured neck of right femur.Approximately 28 years post implantation, patient presented discomfort due to cup loosening and underwent a revision surgery.No product fell into patient.Surgeon articulated that all cup coating was retrieved from acetabulum.Diligence is completed and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned to the post market surveillance team for examination.However, two images were provided showing the reported product as well as a part of the liner.Both products are covered in blood and appear to be located within the operating theater.A large portion of the mesh structure of the fitmore shell has fractured off into multiple fragments, with several patches of tissue as well as blackened tissue attached to it.However, a large portion of the mesh structure is also free of any tissue and/or bone on growth.No product id can be identified on the images.No screws can be identified on the images.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Due to insufficient product information, the compatibility of the involved products could not be verified.Review of the complaint history found no additional related complaints for this item.Due to the lack of the lot number, an additional lot search could not be performed.A screenshot of a portion of the initial surgical report dated on (b)(6) 2006 was provided.Indication for surgery is severe osteoarthritis of the right hip with a healed fractured neck of the right femur.The procedure for the surgery performed was a removal of the zimmer hip screw and a right tha.It is noted within the surgical report that two screws were used for initial fixation of the fitmore shell.The joint was noted as being stable.No further medical records such as surgical report for the revision surgery or radiographs were provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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

It was reported that severe osteoarthritis of the right hip with a healed fractured neck of right femur.Patient presented discomfort due to cup loosening and underwent a revision surgery.No product fell into patient.Surgeon articulated that all cup coating was retrieved from acetabulum.Diligence is completed and additional information on the reported event is unavailable at this time.

• Brand Name: FITMORE®, SHELL WITH SCREW CONES, UNCEMENTED, 56/KK
• 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: 18446581
• MDR Text Key: 332143736
• Report Number: 0009613350-2024-00009
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024384354
• UDI-Public: (01)00889024384354
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 01/04/2024
• 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: 0100024556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization