MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X34MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10.Blunt tip screw, ã¿ 4x36mm item#47248603640 lot#3091446, blunt tip screw, ã¿ 4x38mm item#47248603840 lot#3169760, cortical bone screw, ã¿ 4x24mm item#47248612440 lot#3174997, cortical bone screw, ã¿ 4x26mm item#47248612440 lot#3164766, washer small item#47248800004 lot#3087027, proximal humerus nail cap, 0mm item#47248801000 lot#3081964.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: 0009613350-2024-00034.
Event or Problem Description
It was reported that operation was performed with ann nail approximately 4 months ago.After 2 months from the initial, surgeon found one of the proximal screw was backed out from the proper position.The surgeon will keep an eye on the patient condition as well, but no revision has been planned so far.Diligence is complete and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
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.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: 0009613350-2024-00034-1.
Event or Problem Description
Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: BLUNT TIP SCREW, ÿ 4X34MM
• 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: 18778344
• Report Number: 0009613350-2024-00033
• Device Sequence Number: 18238536
• Product Code: HSB
• UDI-Device Identifier: 00889024505414
• UDI-Public: (01)00889024505414(17)260922(10)3091296
• 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,Followup
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/22/2026
• Device Model Number: N/A
• Device Catalogue Number: 47248603440
• Device Lot Number: 3091296
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Unknown