MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised due to loosening.The cup and screws were explanted.
Additional Manufacturer Narrative
(b)(4).D10: 00875705602 continuum tm shell multi 56 kk 63257064 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 63420071 00625006515 bone screw self-tapping 6.5 mm dia.15 mm length 63420075 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length 63530640 00625006540 bone screw self-tapping 6.5 mm dia.40 mm length 63566054 g2: foreign: australia customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Corrected: a1, d4 (expiration date, udi #).The reported event was confirmed by review of x-rays.Visual examination of the provided pictures identified the explanted shell and screws, covered in bio-debris.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty.Loosening of the acetabular cup is demonstrated.Steep acetabular cup lateral angle of inclination, high placement of the acetabular cup, protrusio acetabuli and generalized reduced bone mineral density are all risk factors for acetabular cup loosening.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• Common Device Name: PROSTHESIS, HIPS
• 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: 23616759
• Report Number: 0002648920-2025-00327
• Device Sequence Number: 21354942
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)261031(10)63517707
• 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 Implanted Year: 2017
• 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): 04/06/2026

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 Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 63517707
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female