MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	2051-2046
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's hip was revised due to shell loosening.The shell, liner and head were revised to a competitor shell and liner with a new stryker head.Rep confirmed that no further information will be release by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding loosening involving a securfit shell was reported.The event was not 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 of the provided medical records by a clinical consultant indicated: 'confirmation of event: i can confirm that the patient had a total hip arthroplasty since i was able to see an x-ray with the implant in place.I cannot confirm loosening of the shell nor can i confirm that the patient underwent revision since i have no documentation provided.Root cause analysis: assuming the event is loosening of the acetabular shell, the root cause of this event cannot be determined with certainty.The causes of acetabular loosening are multifactorial including surgical technique, the cup position and initial fixation, patient factors including activity level, lifestyle and bmi can contribute.With the information provided i would not assign any causality to the acetabular implant itself.' 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: it was reported that the patient's hip was revised due to shell loosening.The shell, liner and head were revised to a competitor shell and liner with a new stryker head.A review of the provided medical records by a clinical consultant indicated: 'confirmation of event: i can confirm that the patient had a total hip arthroplasty since i was able to see an x-ray with the implant in place.I cannot confirm loosening of the shell nor can i confirm that the patient underwent revision since i have no documentation provided.Root cause analysis: assuming the event is loosening of the acetabular shell, the root cause of this event cannot be determined with certainty.The causes of acetabular loosening are multifactorial including surgical technique, the cup position and initial fixation, patient factors including activity level, lifestyle and bmi can contribute.With the information provided i would not assign any causality to the acetabular implant itself.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23248708
• Report Number: 0002249697-2025-01072
• Device Sequence Number: 21438925
• Product Code: MEH
• UDI-Device Identifier: 07613327020281
• UDI-Public: 07613327020281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 06/30/2000
• Device Catalogue Number: 2051-2046
• Device Lot Number: 16967903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/1995
• 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