MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT FEMORAL STEM 12/14 NECK EXTRA EXT OFFSET SIZE 2 130 MM; PROSTHESIS, 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	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial hip procedure.Subsequently, the patient had a fall at home approximately 3 years later which resulted in a peri-prosthetic fracture around cpt stem.The implant was not broken.No implants were revised, and the bone fracture was repaired.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00801803602 lot# 64542661 femoral head sterile product do not resterilize 12/14 taper.Cat# 00631005836 lot# 64610357 liner 10 degree elevated rim 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell.Cat# 00620205822 lot# 64164996 shell porous with cluster holes 58 mm.Cat# 00801102032 lot# 64663094 allen medullary cement plugs 1-32 mm diameter flange/16mm diameter core store in cool dry place.Cat# 66044274 lot# w104 palacospro 75g.Cat# 66044274 lot# w104 palacospro 75g.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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;g3;h2;h3;h6.H6: component code: mechanical (g04) stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a fall at home which resulted in a peri-prosthetic fracture around the cpt stem.The implant was not broken.The cause of the fall is unknown.Radiographs were provided; however, a single ct slice is not sufficient for diagnostic purposes.A definitive root cause cannot be determined.The complaint is confirmed due to the medical records provided.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 EXTRA EXT OFFSET SIZE 2 130 MM
• Common Device Name: PROSTHESIS, 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: 19980151
• Report Number: 0002648920-2024-00254
• Device Sequence Number: 19528479
• Product Code: JDI
• UDI-Device Identifier: 00889024145801
• UDI-Public: (01)00889024145801(17)291031(10)64560608
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 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: 00811400230
• Device Lot Number: 64560608
• 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: 07/27/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 87 KG