MAUDE Adverse Event Report: ZIMMER GMBH ANTE/RETROGRADE HUMERUS, ÿ 9.5X280MM; IMPLANT, TRAUMA

Catalog Number	47-2497-280-09
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: blunt tip screw, #item 47248604640, #lot 3152738; blunt tip screw, #item 47248603840, #lot unknown; ante/retrograde humerus nail cap, #item 47248800800, #lot 3010698; cortical bone screw, #item 47248612440, #lot 3167005.Therapy date: (b)(6) 2023.G2: switzerland.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient after a month post implantation went for a revision surgery for the removal of a screw due to migration because of osteoporosis the subject is reported as improved/recuperated.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6.Corrected: d4.No product was returned or pictures provided; a product evaluation could not be performed.The reported products were reviewed for compatibility with no issues noted.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.For ref (b)(4) due to the lack of the lot number, an additional lot search could not be performed.Medical records were not provided.It was noted that the screw loosening/migration is due to osteoporosis.However, there are no further documents available that could confirm this.As the devices involved in the reported event were not returned for investigation, a further product evaluation could not be performed and the condition of the products are unknown.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.
Event or Problem Description
No additional event information.

• Brand Name: ANTE/RETROGRADE HUMERUS, ÿ 9.5X280MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21875723
• Report Number: 0009613350-2025-00327
• Device Sequence Number: 15383323
• Product Code: HSB
• UDI-Device Identifier: 00889024506220
• UDI-Public: (01)00889024506220(17)300630(10)3031575
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 09/29/2025

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: 47-2497-280-09
• Device Lot Number: 3031575
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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 Age: 49 YR
• Patient Sex: Male