MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT COLLARLESS STEM COCR MOLD#273; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 1003-0425

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 01/29/2014

Event Type  Injury  

Event Description

It was reported that the stem broke.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information (including x-rays and medical records) was requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding crack/fracture involving an omnifit stem was reported.The event was confirmed.Method & results: -device evaluation and results: a review of the photo provided noted an explanted proximal stem with the head attached.The fracture is noted at the distal end of the stem.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "x-ray printouts include an undated ap and lateral of the right hip demonstrating a hybrid right total hip arthroplasty, which is reduced.The acetabulum is in nominal position.There is a transverse fracture of the stem at the junction of the proximal and middle third with a slight varus displacement and a radiolucency around the proximal cement mantel.There is a fractured cement mantel at the site of the stem fracture.It is also noted that an extended neck modular head is affixed to the stem.There is a photograph of the explanted proximal stem with the head attached and the transverse fracture noted at the distal end of the fragment.No operative reports, no clinical or past medical history, and no examination of the explanted component are available.In this obese female patient, failure of proximal cement fixation resulted in cyclic loading at the fracture of the loose proximal stem and the well-fixed distal stem, which led to inevitable fatigue fracture after eighteen years in situ.Material analysis of the explanted component would confirm this mechanism and rule out factors of faulty component design, manufacturing or materials as contributing to this late clinical situation." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed however the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of medical records provided by a consulting clinician indicated: "in this obese female patient, failure of proximal cement fixation resulted in cyclic loading at the fracture of the loose proximal stem and the well-fixed distal stem, which led to inevitable fatigue fracture after eighteen years in situ." if the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the stem broke.

• Brand Name: OMNIFIT COLLARLESS STEM COCR MOLD#273
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3645599
• MDR Text Key: 4207668
• Report Number: 0002249697-2014-00518
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K844818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2000
• Device Catalogue Number: 1003-0425
• Device Lot Number: 92N186
• Other Device ID Number: STERILE LOT# 9510G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/1995
• 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
• Patient Age: 73 YR
• Patient Weight: 104