MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JOINT REPLACEMENT_PRODUCT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? not returned to the manufacturer.

Event Description

Patient's left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A size 9 omnifit stem, 26 +5 metal head, and secur-fit 26mm 10° liner were revised.Rep confirmed there are no allegations against the head or liner.

Manufacturer Narrative

An event regarding periprosthetic fracture involving an unknown omnifit stem was reported.The event was confirmed through clinician review of the provided x-ray.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi - 2268632 involving a male dob (b)(6) 1935 who underwent a left tha approximately (b)(6) 1992 and a revision on (b)(6) 2019.Event description ".Left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A size 9 omnifit stem, 26/+5 metal head, and 26/10 degree liner were revised.There are no allegations against the head or liner."x-ray - 1 undated ap left hip with an uncemented tha, no screws in the acetabulum, minimal poly wear, reduced with components in nominal position.A long, spiral displaced periprosthetic femur fracture beginning at the lateral cortex 4 cm distal to the greater trochanter and extending distally beyond the x-ray field of vision.No clinical or past medical history, no operative reports, no serial x-rays, no examination of explanted components, and no patient demographics available.After 27 years in situ, a traumatic periprosthetic fracture is not likely due to factors of implant design, manufacturing or materials.The single x-ray confirms the event description, but insufficient data is presented to generate a report on this case." 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: the reported event of femoral periprosthetic fracture was confirmed by clinician based on the x-ray provided.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as clinical or past medical history, operative reports, serial x-rays, examination of explanted components and patient demographics are required to complete the investigation and determine a 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.

Event Description

Patient's left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A size 9 omnifit stem, 26 +5 metal head, and secur-fit 26mm 10° liner were revised.Rep confirmed there are no allegations against the head or liner.Update: patient's left hip was revised due to a femoral periprosthetic fracture sustained in a fall.A size 9 omnifit stem, 26 +5 metal head, and secur-fit 26mm 10° liner were revised.Rep confirmed there are no allegations against the head or liner.Rep has additional pictures to provide, and reported that no further information will be available.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_PRODUCT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9527505
• MDR Text Key: 185719282
• Report Number: 0002249697-2019-04126
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR