MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 20MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	7030-6520
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to cup dislocation with screw fracture.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a hip screw was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review with a clinical consultant indicated "i have reviewed the documentation provided including the product inquiry cover sheet and an ap x-ray of a left tha.Event description: revision surgery due to cup dislocation with screw fracture the x-ray image shows an acetabular component with bone prosthetic lucencies and a broken fixation screw.The cup has shifted in to a vertical orientation.Cup displacement with a broken fixation screw is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review with a clinical consultant indicated "i have reviewed the documentation provided including the product inquiry cover sheet and an ap x-ray of a left tha.Event description: revision surgery due to cup dislocation with screw fracture.The x-ray image shows an acetabular component with bone prosthetic lucencies and a broken fixation screw.The cup has shifted in to a vertical orientation.Cup displacement with a broken fixation screw is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided.No further investigation for this event is possible at this time.If device/additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 20MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23642898
• Report Number: 0002249697-2025-01374
• Device Sequence Number: 10122883
• Product Code: LPH
• UDI-Device Identifier: 07613327345094
• UDI-Public: 07613327345094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 7030-6520
• Device Lot Number: H2XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian