MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HFX HIP STEM SIZE #08 127; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6076-0830A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an omnifit stem was reported.The event was not confirmed.Method & results: product evaluation and results: the device was not returned.Visual inspection of the received image of the device noted an explanted stem and head covered in blood.Nothing remarkable observed.Dimensional, functional and material analysis were not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusions: it was reported that the patient's right hip was revised due to a femoral periprosthetic fracture caused by a fall.Visual inspection of the received image of the device noted an explanted stem and head covered in blood.Nothing remarkable observed.The event could not be confirmed nor the exact cause could be determined because insufficient information was provided.Further information such as pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If device is returned or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to a femoral periprosthetic fracture caused by a fall.A 46 x 28 uhr universal head bipolar component, 28+0mm c-taper lfit head, and size 8 onmifit stem were revised to a uhr universal head bipolar component of the same size with a 28 -4mm ceramic v40 head and a restoration modular hip system.There are no allegations against the head or bipolar component.Rep confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: OMNIFIT HFX HIP STEM SIZE #08 127
• 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: 11590255
• Report Number: 0002249697-2021-00569
• Device Sequence Number: 17338579
• Product Code: JDI
• UDI-Device Identifier: 07613327023572
• UDI-Public: 07613327023572
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K031744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 09/30/2025
• Device Model Number: 6076-0830A
• Device Catalogue Number: 6076-0830A
• Device Lot Number: 5Y4J8T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/30/2021
• 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: 64 YR
• Patient Weight: 71