MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH; PROSTHESIS, HIP

Catalog Number	00625006550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the elderly patient was revised approximately 1 (one) year after initial implantation because she fell on her hip and one of the screws broke.The surgeon thought that it happened before the cup had got adequate fixation and because of her age, dislodged.The surgeon believes her age and fragility was the cause of her fall.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D4: it is unknown which screw broke out of the following: zimmer bone screw self-tapping 6.5 mm dia.50 mm length.Part # 00625006550.Lot # j7598655.Zimmer bone screw self-tapping 6.5 mm dia.40 mm length.Part # 00625006540.Lot # j7353484.Zimmer bone screw self-tapping 6.5 mm dia.50 mm length.Part # 00625006550.Lot # j7598655.Zimmer bone screw self-tapping 30 mm length 6.5 mm dia.Part # 00662406530.Lot # 66898809.Zimmer bone screw self-tapping 6.5 mm dia.35 mm length.Part # 00625006535.Lot # j7426229.Zimmer bone screw self-tapping 6.5 mm dia.20 mm length.Part # 00625006520.Lot # j7655712.Zimmer bone screw self-tapping 6.5 mm dia.30 mm length.Part # 00625006530.Lot # j7545307.D6a: unknown day in (b)(6) 2024.D10: zimmer 50mm x 10mm thickness acetabular augment.Part # 00489405010.Lot # 66539774.G2: foreign: australia customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the devices being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h1; h2; h3; h4; h6, h10.Visual examination of the provided pictures identified explanted cup, bio-debris present, cannot be used to confirm the reported event.No picture provided of the reported fractured screw.Devices not returned, further analysis cannot be made.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23811679
• Report Number: 0002648920-2025-00350
• Device Sequence Number: 7621568
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)330825(10)J7598655
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/03/2026

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: 00625006550
• Device Lot Number: J7598655
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female