MAUDE Adverse Event Report: ZIMMER GMBH FITMOR HIP STEM B EXT OFFS S10; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/08/2024

Event Type  Injury  

Event Description

It was reported that patient underwent revision post-implantation due to a broken stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2: report source switzerland.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).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: FITMOR HIP STEM B EXT OFFS S10
• 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: 18989053
• MDR Text Key: 338736647
• Report Number: 0009613350-2024-00125
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024591936
• UDI-Public: (01)00889024591936(17)220331(10)2645952
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 0100551310
• Device Lot Number: 2645952
• 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: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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: ITEM # 0101012367, COCR HEAD, LOT # 2738374
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male