MAUDE Adverse Event Report: ZIMMER GMBH PROXIMAL HUMERUS, LEFT, ÿ 11X160MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Blunt tip screw, ã¿ 4x52mm item# 47248605240 lot# 3086989.Blunt tip screw, ã¿ 4x42mm item# 47248604240 lot# 3142306.Blunt tip screw, ã¿ 4x36mm item# 47248603640 lot# 3091449.Humerus ball nose guidewire, sterile item# 110035668 lot# 3148972.Cortical bone screw, ã¿ 4x26mm item# 47248612640 lot# 3139153.Proximal humerus nail cap, ã¿ 11x2.5mm item# 47248801102 lot# 3010713.Proximal humerus nail cap, ã¿ 11x5mm item# 47248801105 lot#3054474.G2.Report source: japan.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.Review of complaint histories identified additional similar complaints for the reported products and additional similar complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.It can be assumed that multiple contributing factors, related to either patient condition and behavior or implantation procedure, contributed to the migration of the screws.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism of the affixus nail as a potential contributing factor.As part of the deeper investigation, a scientific literature search was conducted and a systematic review of the outcome of intramedullary nailing for acute proximal humerus fracture showed that screw migration and perforation into the joint is the second most common complication following secondary loss of reduction.In addition, scientific literature of competitor and predicate devices were assessed.This review has shown that the affixus® natural nail® proximal humeral system performs better and/or in equal range in comparison with legally marketed similar devices in conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00075.
Event or Problem Description
It was reported that operation was performed with ann nail, after 8 months from the initial, surgeon found #1 proximal screw was backed out from the proper position.The patient complained of pain and a revision surgery was performed to remove the migrated screw.Diligence is completed and additional information on the reported event is unavailable at this time.

• Brand Name: PROXIMAL HUMERUS, LEFT, ÿ 11X160MM
• Common Device Name: PROSTHESIS, HIP
• 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: 18924484
• Report Number: 0009613350-2024-00074
• Device Sequence Number: 21193782
• Product Code: HSB
• UDI-Device Identifier: 00889024505827
• UDI-Public: (01)00889024505827(17)310929(10)3085714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 03/18/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47249616111
• Device Lot Number: 3085714
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female