MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER X3 RIMFIT ID40 OD58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	63094058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: device: delta un-fem hd 40mm r40 16/18; cat#: 6519-1-040; lot# 12661156.Device: exeter v40 stem 50mm no 1; cat#: 0580-1-501; lot# g8248549.Device: uni adaptor sleeve v40 ti; cat#: 6519-t-204; lot# 14808754.Device: exeter 2.5 i m plug 12mm; cat#: 09390112; lot# 331shn0154.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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
The patient had a primary left tha out of cors scope.On (b)(6) 2019 the patient has a periprosthetic joint infection and is entered into cors with a revision for infection.The patient developed again infection of the left hip and underwent revision for pji were all components exchanged on (b)(6) 2023.The patient presents with recurrent left hip infection and is revised again on (b)(6) 2023.All components were exchanged.
Additional Manufacturer Narrative
Correction to the lot for the following device: device: exeter 2.5 i m plug 12mm; cat#: 09390112; lot# n0154.Reported event: an event regarding infection involving an exeter 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: no medical records were received for review with a clinical consultant.-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 or sterile lot referenced.Conclusions: it was reported that the patient was revised 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.Further information such as pathology reports 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
The patient had a primary left tha out of cors scope.On (b)(6) 2019 the patient has a periprosthetic joint infection and is entered into cors with a revision for infection.The patient developed again infection of the left hip and underwent revision for pji were all components exchanged on (b)(6) 2023.The patient presents with recurrent left hip infection and is revised again on (b)(6) 2023.All components were exchanged.

• Brand Name: EXETER X3 RIMFIT ID40 OD58
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21384853
• Report Number: 0002249697-2025-00203
• Device Sequence Number: 8461723
• Product Code: JDI
• UDI-Device Identifier: 07613327072334
• UDI-Public: 07613327072334
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 01/31/2024
• Device Catalogue Number: 63094058
• Device Lot Number: LHX607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 113 KG