MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFLEX M-HA HIP STEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6042-0830

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Ambulation Difficulties (2544)

Event Date 11/25/2020

Event Type  Injury  

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.

Event Description

It was reported by the sales rep that on the (b)(6) 2020 a "revision [was] performed at (b)(6) memorial today with doctor.Pt.Presented with a periprosthetic fracture of a ¿25+ year old hemiarthroplasty¿ no other info concerning original/primary surgery is known.".

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture involving a omnifit stem was reported.The event was confirmed via medical review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: photos show a recently explanted device with biological material throughout.There are no remarkable observations to note.Clinician review: a review of the provided medical information by a clinical consultant indicated: a review of the provided medical information by a clinical consultant indicated: re pi - which represents a male patient, dob (b)(6) 1936 described as 60 inches tall and weighing 120 pounds.His date of implantation is listed as (b)(6) 1995 approx.And explantation (b)(6) 2020.The event description states: ".Revision.Periprosthetic fracture of a 25 year old hemiarthroplasty." undated x-ray: ap hip side not marked uncemented omniflex hemiarthroplasty, reduced, with comminuted periprosthetic fracture of proximal femur.(b)(6) 2020 implant labels: 9 dall-miles cable and sleeve sets, small dall-miles trochanteric grip, 195/17 restoration modular stem, 21/@0 v-40 body, (b)(4) v-40 lfit head, 40/26 uhr bipolar.No clinical or pmh,no dated serial x-rays, no operative reports, no examination of explanted components.While the submitted x-ray appears to confirm the event description, insufficient data is presented to create a medical report for this case.Product 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.Conclusions: a review of the provided medical information by a clinical consultant indicated: re pi - which represents a male patient, dob (b)(6) 1936 described as 60 inches tall and weighing 120 pounds.His date of implantation is listed as (b)(6) 1995 approx.And explantation (b)(6) 2020.The event description states: ".Revision.Periprosthetic fracture of a 25 year old hemiarthroplasty." undated x-ray: ap hip side not marked uncemented omniflex hemiarthroplasty, reduced, with comminuted periprosthetic fracture of proximal femur.(b)(6) 2020 implant labels: 9 dall-miles cable and sleeve sets, small dall-miles trochanteric grip, 195/17 restoration modular stem, 21/@0 v-40 body, (b)(4) v-40 lfit head, 40/26 uhr bipolar.No clinical or pmh,no dated serial x-rays, no operative reports, no examination of explanted components.While the submitted x-ray appears to confirm the event description, insufficient data is presented to create a medical report for this case.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.

Event Description

It was reported by the sales rep that on the (b)(6) 2020 a "revision [was] performed at (b)(6) today with doctor.(b)(6).Presented with a periprosthetic fracture of a ¿25+ year old hemiarthroplasty¿ no other info concerning original/primary surgery is known.".

• Brand Name: OMNIFLEX M-HA HIP STEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11035864
• MDR Text Key: 222283309
• Report Number: 0002249697-2020-02703
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K920193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 6042-0830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/16/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR