MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT CROSSFIRE 10 DEG CROSSFIRE UHMWPE INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2041C-2658
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Tha primary surgery was performed on (b)(6) 2003.Dislocation was confirmed and revision surgery was performed on (b)(6) 2024.(event#1).This pi is for event#1.Event#2 (intra-op instrument damage) is reported in another pi.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a omnifit liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: product history review could not be performed due to insufficient information.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Tha primary surgery was performed on (b)(6) 2003.Dislocation was confirmed and revision surgery was performed on (b)(6) 2024.(event#1).This pi is for event#1.Event#2 (intra-op instrument damage) is reported in another pi.

• Brand Name: OMNIFIT CROSSFIRE 10 DEG CROSSFIRE UHMWPE INSERT
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20756130
• Report Number: 0002249697-2024-01614
• Device Sequence Number: 15600202
• Product Code: LPH
• UDI-Device Identifier: 04546540035660
• UDI-Public: 04546540035660
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 06/30/2007
• Device Catalogue Number: 2041C-2658
• Device Lot Number: 03995201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2002
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 94 KG