MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	625-0T-28D
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Tha surgery was performed in (b)(6) 13 years ago.X-rays showed osteolysis and implant damage.After consultation between the doctor and the competitor's sales rep, the product was most likely a stryker product.The detail of the product is unknown.Revision surgery is scheduled to take place in the near future, but the date has not yet been determined.Product appears to be trident alumina insert.
Event or Problem Description
The surgery was performed in shanghai 13 years ago.X-rays showed osteolysis and implant damage.After consultation between the doctor and the competitor's sales rep, the product was most likely a stryker product.The detail of the product is unknown.Revision surgery is scheduled to take place in the near future, but the date has not yet been determined.Product appears to be trident alumina insert.
Additional Manufacturer Narrative
Reported event: an event regarding osteolysis involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was unknown.Complaint history review: could not be performed as lot code information was unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including office notes, pre and post operative x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 20696319
• Report Number: 0002249697-2024-01573
• Device Sequence Number: 3714472
• Product Code: MRA
• UDI-Device Identifier: 04546540516831
• UDI-Public: 04546540516831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 625-0T-28D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown