MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 95MM; AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX95MM

Catalog Number	814510095
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: unknown, unknown a/r screw; lot#: unknown.G2: foreign: poland.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip surgery on and unknown date.Subsequently, the implant has loosened due to an unknown reason on and unknown date.Multiple attempts have been made to obtain additional information, but no response has been received.
Event or Problem Description
It was reported that the patient underwent an initial hip surgery on an unknown date.Subsequently, the implant loosened and fell into the patient's acetabulum approximately two (2) and a half months ago.The patient will not be revised due to unknown health problems.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.Based on the information provided, images were not submitted for mmi review as they were unable to be determine which images were for which patient, and there is a linked complaint with the same 4 images as well.A definitive root cause cannot 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2; a3; b4; b5; b6; d2; g2; g3; g6; h1; h2; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip orthopedic hardware with gamma nail which protrudes to the acetabular surface of the remaining right femoral head with significant radiolucency surrounding the gamma nail suggesting possible osteolysis, as well as what appears to be partial withdrawal of the gamma nail after placement.The additional information provided does not change the root cause of the previous investigation.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: HFN LAG SCREW 10.5MM X 95MM
• Common Device Name: AFFIXUS HIP FRACTURE NAIL LAG SCREW 10.5MMX95MM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19060202
• Report Number: 0001825034-2024-00966
• Device Sequence Number: 5897635
• Product Code: HSB
• UDI-Device Identifier: 00887868566882
• UDI-Public: (01)00887868566882(17)330830(10)L19652B
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 814510095
• Device Lot Number: L19652B
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/08/2024; 08/28/2024; 10/17/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/23/2024; 09/06/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male