MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	7030-6525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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
Dislocation of the cup and screw breakage occurred.Revision surgery is planned on (b)(6) 2025.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a hip screw was reported.The event was confirmed method & results: -product evaluation and results: visual inspection of the returned screw indicated that the screw had fractured approximately 20mm from the head.The fracture appears consistent with a fracture in overload consistent the shell pulling away from the acetabulum.-clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient underwent a total hip arthroplasty since i was able to review an x-ray with the implant in place.I can also confirm that the cup loosened, spun out and at least one screw was fractured.I can confirm this also because i was able to see an x-ray with these findings.I cannot definitely confirm that the patient had explanation and revision surgery since i have no documentation other than a note in the product inquiry summary.I have no doctors notes, operation notes, or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The root cause of loosening and spin out of an acetabular cup five months after implantation are multifactorial, including surgical technique in the way, the cup was positioned and initially stabilized, patient factors, including lifestyle, activity level and bmi.Trauma could play a role, but no mention of trauma was noted in the product inquiry summary.With the information provided, i would not assign any causality to the implant itself." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient underwent a total hip arthroplasty since i was able to review an x-ray with the implant in place.I can also confirm that the cup loosened, spun out and at least one screw was fractured.I can confirm this also because i was able to see an x-ray with these findings.I cannot definitely confirm that the patient had explanation and revision surgery since i have no documentation other than a note in the product inquiry summary.I have no doctors notes, operation notes, or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The root cause of loosening and spin out of an acetabular cup five months after implantation are multifactorial, including surgical technique in the way, the cup was positioned and initially stabilized, patient factors, including lifestyle, activity level and bmi.Trauma could play a role, but no mention of trauma was noted in the product inquiry summary.With the information provided, i would not assign any causality to the implant itself." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 25MM
• 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: 21838676
• Report Number: 0002249697-2025-00411
• Device Sequence Number: 18168217
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: 07613327345001
• 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): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 7030-6525
• Device Lot Number: GZ7A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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 Age: 68 YR
• Patient Sex: Male