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

Catalog Number	6097-0835
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	10/29/2019
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
As reported: "right revision tha.Diagnosis: failed right total hip.No further information available per hospital." rep has provided an x-ray and explant pictures.Update 31/october/2019: spoke to rep.Patient was revised due to stem loosening.The stem, head, liner, and dall-miles cable were revised.Rep confirmed there were no allegations against the head and liner.No allegations against the dall- miles cable were reported to the rep.After implanting a constrained liner, the surgeon decided he wanted to go with a non- constrained liner instead (no allegations against the constrained liner).When trying to explant the constrained liner, the shell became dislodged intra-operatively and was revised (no prior allegations to the shell or plan to revise it).Patient's bone quality is unknown.Patient was revised to a cemented exeter stem, trident ii shell, poly liner and 36 -5 metal head.
Event or Problem Description
As reported: "right revision tha.Diagnosis: failed right total hip.No further information available per hospital." rep has provided an x-ray and explant pictures.Update 31/october/2019: spoke to rep.Patient was revised due to stem loosening.The stem, head, liner, and dall-miles cable were revised.Rep confirmed there were no allegations against the head and liner.No allegations against the dall- miles cable were reported to the rep.After implanting a constrained liner, the surgeon decided he wanted to go with a non- constrained liner instead (no allegations against the constrained liner).When trying to explant the constrained liner, the shell became dislodged intra-operatively and was revised (no prior allegations to the shell or plan to revise it).Patient's bone quality is unknown.Patient was revised to a cemented exeter stem, trident ii shell, poly liner and 36 -5 metal head.
Additional Manufacturer Narrative
An event regarding loosening involving an omnifit stem was reported.The event was confirmed via x-rays.Method & results: device evaluation and results: the reported device was not returned however photographs and x-rays were provided for review.The photographs show a recently explanted omnifit stem with some blood spots and the x-ray shows the stem is loose.From the photographs provided there is evidence of loosening for the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided complaint records and x-rays by a clinical consultant indicated ¿x-ray confirms loosened right hip stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.¿ device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided complaint records and x-rays by a clinical consultant indicated ¿x-ray confirms loosened right hip stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.¿ the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, 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.

• Brand Name: OMNIFIT EON 127
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9378383
• Report Number: 0002249697-2019-03871
• Device Sequence Number: 13980029
• Product Code: JDI
• UDI-Device Identifier: 07613327022391
• UDI-Public: 07613327022391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K983226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 6097-0835
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 57