MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one year post implantation of a right total hip arthroplasty, the patient was revised due to a fall resulting in a periprosthetic fracture.Contributing factors to the event were the fall and dementia; however, the cause of the fall is not known.No additional information available.
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: australia.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.H6: component code: mechanical (g04) stem.Product was not returned for evaluation; however, a picture was provided.Visual examination of the provided picture identified the stem with bio debris.No other observations were noted.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: pre-fracture view demonstrates anatomic alignment of the right hip arthroplasty without acute abnormality.A chronic appearing radiolucency is noted along the medial femur near the implant tip.Post-fracture view demonstrates a comminuted and displaced periprosthetic fracture of the right femur.A definitive root cause cannot be determined.Based on the medical record review, the complaint is confirmed.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 is available at the time of this report.

• Brand Name: CPT FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH
• Common Device Name: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19906780
• Report Number: 0002648920-2024-00248
• Device Sequence Number: 7064158
• Product Code: JDI
• UDI-Device Identifier: 00889024145757
• UDI-Public: (01)00889024145757(17)330822(10)66094652
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 00811400100
• Device Lot Number: 66094652
• 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: 07/20/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown