MAUDE Adverse Event Report: ZIMMER GMBH PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problems Separation Failure (2547); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D.10 blunt tip screw, ã¿ 4x44mm item#47-2486-044-40, lot#3076788.Blunt tip screw, ã¿ 4x42mm item#47-2486-042-40, lot#3155804.Ann blunt tip screw 4x42mm item#47-2486-042-40, lot#3152737.Ann blunt tip screw 4x60mm item#47-2486-060-40 ,lot#3091607.Ann cort bone screw 4 x 30mm item# 47-2486-130-40, lot#3155767.Ann cort bone screw 4 x 32mm item# 47-2486-132-40, lot#3091574.Affixus ph nl cap 0mm item#47-2488-010-00 lot#3158999 g2.Report source: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: medwatch's: 0009613350-2023-00644 and 0009613350-2023-00645.

Event Description

It was reported that operation was performed with ann nail on (b)(6) 2023.After 4 weeks from this surgery, surgeon found #1 and #2 proximal screws were backed out from the proper position.The surgeon keeps an eye on the patient condition as well as no revision will be planned so far.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4(udi); e1; e2; e3; g3; h2; h3; h6.H6: investigation findings: malfunction observed.Two radiographs were provided and reviewed by a radiologist.Two views of the right humerus demonstrate an intramedullary rod with multiple fixation screw; the proximal two fixation screws have withdrawn.Comminuted fracture of the proximal humeral diaphysis with lucent fracture line still seen.Glenoid osteophytosis and steopenia.Overall fit and alignment of the implants is appropriate.Perhaps the screws backed out because of the incompletely healed fracture.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.A definitive root cause is unable to 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.

Event Description

It was reported that patient presented approximately 4 weeks post initial surgery and it was found that two proximal screws have backed out of the ann nail system.At this time, no revision surgery is planned.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM
• Type of Device: PROSTHESIS, TRAUMA
• 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: 18184684
• MDR Text Key: 329800466
• Report Number: 0009613350-2023-00643
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47249616011
• Device Lot Number: 3137800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1