MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI SOLIDBACK CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-58F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The site notified stryker on (b)(6) 2025 that dr.Assessed this subject's clinic notes and confirmed there was a loosening of the cup.Persistent non-union fracture (b)(6) 2017 of the posterior column with radiolucency of the acetabulum.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via medical review.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: "i can confirm that the patient had a left total hip arthroplasty at some point in the past since i was able to see an x-ray with the implant in place.I can confirm that the cup is most likely loose but i cannot confirm that a fracture nonunion of the posterior column was present.The root cause of this event cannot be determined with certainty.The causes of late loosening are multifactorial including initial surgical technique in the way the cup was prepared, inserted and positioned and assessed for stability.The quality of the host bone can also play a role, as well as trauma which could contribute to loosening as well as the possibility of a posterior column deformity.Although not definitely seen on the mri the findings could certainly be consistent with a fracture or nonunion.Patient lifestyle, activity level and bmi can also play a role.With the information given 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: it was reported that the patient was revised due to shell migration and loosening.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a left total hip arthroplasty at some point in the past since i was able to see an x-ray with the implant in place.I can confirm that the cup is most likely loose but i cannot confirm that a fracture nonunion of the posterior column was present.The root cause of this event cannot be determined with certainty.The causes of late loosening are multifactorial including initial surgical technique in the way the cup was prepared, inserted and positioned and assessed for stability.The quality of the host bone can also play a role, as well as trauma which could contribute to loosening as well as the possibility of a posterior column deformity.Although not definitely seen on the mri the findings could certainly be consistent with a fracture or nonunion.Patient lifestyle, activity level and bmi can also play a role.With the information given i would not assign any causality to the implant itself." 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: PRIMARY TRIT HEMI SOLIDBACK CUP 58MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22131166
• Report Number: 0002249697-2025-00573
• Device Sequence Number: 20917747
• Product Code: LPH
• UDI-Device Identifier: 07613327040050
• UDI-Public: 07613327040050
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 500-03-58F
• Device Lot Number: MNJ3D9
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2014
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG