MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PHOENIX RETROGRADE NAIL SYSTEM OFFSET END CAP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14-444181
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a shoulder revision approximately four (4) months post-implantation due to the end cap becoming loose from the nail.During the revision, the end cap was replaced and the nail remains implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 14-444230; lot# 388220.G2: foreign - event occurred in japan.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.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
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6; h10.The end cap returned does show signs of use with some damage to the hex feature on the top side of the cap.There is also some damage around the hole of the end cap on the bottom side.The threads of the end cap are also damaged.Measured the end cap and both measurements are conforming to the print specification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: on (b)(6) 2025- intramedullary nail and screw fixation traverses a distal femur fracture.Alignment is anatomic.On (b)(6) 2025- the end cap of the nail is slightly retracted when compared to the earlier exam.Alignment in the ap view is unchanged.Right femur fracture with intramedullary nail and screw fixation.Slight retraction of the femoral nail end cap as noted review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event was confirmed.If any further information 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 further event information available at the time of this report.

• Brand Name: PHOENIX RETROGRADE NAIL SYSTEM OFFSET END CAP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 22187263
• Report Number: 0001825034-2025-01701
• Device Sequence Number: 8588513
• Product Code: HSB
• UDI-Device Identifier: 00887868097669
• UDI-Public: (01)00887868097669(17)290522(10)873970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/12/2025

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: Lay User/Patient
• Device Catalogue Number: 14-444181
• Device Lot Number: 873970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female