MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2852
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Trident all poly constrained acetabular insert has been broken while implanted in patient came to the surgeon after 2 months of the thr revised surgery with complaint of the hip pain.Surgeon got his hip xray done and found that trident constrained acetabular insert was broken.
Additional Manufacturer Narrative
An event regarding crack/fracture and disassociation involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the sole x-ray demonstrates the all polyethylene constrained liner has dislodged from its cement mantle within the acetabulum and the femoral head and stem are dislocated.Failure of a constrained liner with loss of fixation and dislocation is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.-device 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: the sole x-ray demonstrates the all-polyethylene constrained liner has dislodged from its cement mantle within the acetabulum and the femoral head and stem are dislocated.Failure of a constrained liner with loss of fixation and dislocation is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Trident all poly constrained acetabular insert has been broken while implanted in patient patient came to the surgeon after 2 months of the thr revised surgery with complaint of the hip pain.Surgeon got his hip xray done and found that trident constrained acetabular insert was broken.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: ALL POLY CONSTRAINED INSERT 52MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 20553251
• Report Number: 0002249697-2024-01467
• Device Sequence Number: 14253134
• Product Code: KWZ
• UDI-Device Identifier: 07613327025484
• UDI-Public: 07613327025484
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 69-2852
• Device Lot Number: 93813V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Male