MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT M-HA HIP STEM C-TAPER; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Catalog Number	6041-0730
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Original right hip replacement done in 1998 - original medical records not available.Dr revised stem only of right hip, due to loosening.Surgery proceeded as planned, no delay, no adverse consequences pertaining to patient reported.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an omnifit stem was reported.The event was confirmed.Method & results: product evaluation and results: the ceramic head and stem were returned for evaluation.The device were decontaminated before evaluation.There are scratches and marks on the device, which is an evidence that the device was an used implant.Metal transfer marks were observed on the inner taper of the head.Damage consistent with explantation observed.Nothing else remarkable to report.Clinician review: a review with a clinical consultant indicated "the x-ray shows press fit tha in anatomic position.There are radiolucencies around the stem consistent with loss of fixation.It is confirmed that loosening of a femoral stem occurred.No documentation regarding revision surgery was provided.The root cause of this loss of stem fixation cannot be determined from the limited documentation provided." 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 loosening.The ceramic head and stem were returned for evaluation.The device were decontaminated before evaluation.There are scratches and marks on the device, which is an evidence that the device was an used implant.Metal transfer marks were observed on the inner taper of the head.Damage consistent with explantation observed.Nothing else remarkable to report.A review with a clinical consultant indicated "the x-ray shows press fit tha in anatomic position.There are radiolucencies around the stem consistent with loss of fixation.It is confirmed that loosening of a femoral stem occurred.No documentation regarding revision surgery was provided.The root cause of this loss of stem fixation cannot be determined from the limited documentation provided." if additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Original right hip replacement done in 1998 - original medical records not available.Dr revised stem only of right hip, due to loosening.Surgery proceeded as planned, no delay, no adverse consequences pertaining to patient reported.

• Brand Name: OMNIFIT M-HA HIP STEM C-TAPER
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• 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: 19800631
• Report Number: 0002249697-2024-01013
• Device Sequence Number: 8379927
• Product Code: KWL
• UDI-Device Identifier: 07613153324034
• UDI-Public: 07613153324034
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K920231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 09/30/2002
• Device Catalogue Number: 6041-0730
• Device Lot Number: 29212001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/1997
• 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 Sex: Male