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-32F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/02/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by customers solicitor: on or around (b)(6) 2008 the claimant underwent a left hip replacement with a follow up operation on or around the (b)(6) 2009.The head and liner were revised due to infection, it was noted "no obvious signs of infection" in the operative notes.
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.The following devices were also listed in this report: device name#alumina v40-femoral head 32mm, -4mm nk; cat# 6565-0-032; lot# 23690401.Device name#trident psl with purefix ha 54mm; cat# 542-11-54f; lot# 28582501.Device name#acetabular dome hole plug; cat# 2060-0000-1; lot# emmke.Device name#6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# mepmmd.Device name#6.5 cancellous bone screw 30mm; cat# 2030-6530-1; lot#lw9mle.Device name#accolade (127 deg) size 4.5 accolade (127 deg) size 4.5; cat# 6021-4535; lot# 281495702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported by customers solicitor: on or around (b)(6) 2008 the claimant underwent a left hip replacement with a follow up operation on or around the (b)(6) 2009.The head and liner were revised due to infection, it was noted "no obvious signs of infection" in the operative notes.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a ceramic liner was reported.The event for infection was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-medical records evaluation: a review of the provided medical records by a clinical consultant indicated: "event confirmation: a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.Revision surgery can be confirmed.Root cause: the root cause of the primary tha was the root cause of the presumably oa but cannot be defined.The root cause of the wash out was concern for infection.The root cause of the revision surgery cannot be stated, but infection appeared to be the actual cause of the hip problem.Subsequent revisions were due to infection." -device history review: not performed as the lot number is unknown.-complaint history review: not performed as the lot number is unknown.Conclusions: it was reported that the patient was revised due to infection.A review of the provided medical records by a clinical consultant indicated: "event confirmation: a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.Revision surgery can be confirmed.Root cause: the root cause of the primary tha was the root cause of the presumably oa but cannot be defined.The root cause of the wash out was concern for infection.The root cause of the revision surgery cannot be stated, but infection appeared to be the actual cause of the hip problem.Subsequent revisions were due to infection." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.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.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20155568
• Report Number: 0002249697-2024-01218
• Device Sequence Number: 4235289
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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-32F
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 02/04/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female