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	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 010000662; g7 pps ltd acet shell 50d (b)(6).00625006520; bone screw self-tapping 6.5 mm dia.20 mm length (b)(6).G2: foreign: china.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that postoperative findings revealed that the acetabular screw had passed through the screw hole of the acetabular cup.No plan to remove the screw.Two product labels were submitted; however, the surgeon cannot confirm which screw is the complaint.
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, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A radiograph was provided and reviewed by a health care professional.Review of the available records identified the following: postoperative ap x-ray of the right hip shows noncemented total hip arthroplasty components in place.The tip of the femoral stem is excluded.Otherwise the femoral component is unremarkable.The acetabular cup is associated with 2 screws superiorly.The more medial of the screws has passed through the screw hole of the acetabular cup and as advanced too far, and is no longer associated with the acetabular cup.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: 23535036
• Report Number: 0002648920-2025-00309
• Device Sequence Number: 13308742
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)340109(10)66505434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 66505434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: Other
• Patient Sex: Unknown