MAUDE Adverse Event Report: ZIMMER GMBH TRIAL HEAD, M, ø 28, TAPER 12/14; FEMORAL HEAD TRIAL PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: hungary the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the trial head was accidentally left somewhere in the patient during the surgery, but the original implant was implanted on the stem.The patient did not agree to be reoperated to remove the trial femoral head.It was reported a delay of 10 minutes.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated/corrected: e1; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of all relevant device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.The trial head involved in the reported event is made from polyphenysulfone (ppsu) with baso4 (green ball head) and is intended to be used for direct body contact for less than 24 hours.According to iso 10993-1:2018 trial heads are categorized as external communicating device with contact to tissue/bone and a contact duration of less than 24h.As such, biocompatibility tests (cytotoxicity, sensitization, irritation, systemic acute toxicity) were conducted following iso 10993-1 guidelines for the intended short-term use and it was verified that ppsu with baso4 is approved for its intended use.Based on the biocompatibility tests, it is not possible to assess the long-term effect of the trial head material in the human body.Additionally, a review with internal health care professionals noted that the patient's potential clinical signs and symptoms would depend on the exact location of the provisional head.Since the precise location has not been provided, it is currently not possible to predict any specific signs or symptoms that the patient might experience.Nevertheless, as per the instructions for use (ifu) d011500192 ed.2023/08, any decision to leave or remove any instrument left in the patient is at the surgeon's ultimate discretion and must take into account the associated risks.Based on the available information, the reported event can be confirmed and the root cause of the reported issue is attributed to off-label use.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information at this time.

• Brand Name: TRIAL HEAD, M, ø 28, TAPER 12/14
• Common Device Name: FEMORAL HEAD TRIAL PROSTHESIS
• 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: 20360773
• Report Number: 0009613350-2024-00477
• Device Sequence Number: 20836148
• Product Code: JDI
• UDI-Device Identifier: 00889024283480
• UDI-Public: (01)00889024283480(11)220117(10)4504478745
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0101559228
• Device Lot Number: 4504478745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown