MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT EON 127; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6097-0630

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 04/04/2023

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to instability and pain.Intra-operatively, the cemented stem was also found to be aseptically loose.A hemi hip construct was removed and a total hip construct implanted.

Manufacturer Narrative

An event regarding loosening involving an omnifit stem was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem with blood and tissue visible on the trunnion and stem neck.The device appears otherwise unremarkable.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 referenced.Conclusions: it was reported that the patient was revised due to loosening and that intraoperatively, the stem was observed to have loosened.The reported devices were not returned however photographs were provided for review.The photographs show a recently explanted stem with blood and tissue visible on the trunnion and stem neck.The stem appears otherwise unremarkable.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays 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.H3 other text : not returned.

• Brand Name: OMNIFIT EON 127
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16831683
• MDR Text Key: 314172784
• Report Number: 0002249697-2023-00445
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327022421
• UDI-Public: 07613327022421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 6097-0630
• Device Catalogue Number: 6097-0630
• Device Lot Number: 9R4D3R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG