MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; IMPLANT

Catalog Number 0580-1-440

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 06/26/2014

Event Type  Injury  

Event Description

The letter from thompsons solicitors reported that on (b)(6) 2014, while the patient was at home, upon turning around he allegedly felt pain from his left hip.The pain allegedly got worse on (b)(6) 2014 and he attended a&e.He was asked to return on (b)(6) 2014 for a full x-ray.The x-ray was reported to reveal that the prosthetic component had fractured.The patient was scheduled for surgery on (b)(6) 2014 to have the hip replaced again but on trying to remove the original stem / rod, the femur was reported to have cracked.The patient allegedly had to have a longer stem and also two bands around the femur to strengthen it.The solicitor alleges that the cracking of the femur has resulted in prolonged recovery period, pain and discomfort.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown exeter stem.The information in this report was provided by an attorney.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed.Method and results: device evaluation and results: not performed, the device was not returned to stryker.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: multiple factors have contributed to an overload condition around the proximal area of the exeter stem culminating in a fatigue fracture of the device.There is the proximal lateral cement mantle defect, the varus position of the stem increasing the jrf(joint reaction force) while the eccentric medial location of the stem in the canal contributes to weakening of the medial cement mantle all causing overload on the proximal stem section of a somewhat undersized and thereby weaker stem.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event was a combination of a cement mantle defect and the varus position of an undersized stem resulting in an overload condition and fatigue fracture of the device.Further information such as return of the device, operative reports as well as patient history and follow-up notes would be helpful in completing a more comprehensive investigation.

Event Description

The letter from thompsons solicitors reported that on (b)(6) 2014, while the patient was at home, upon turning around he allegedly felt pain from his left hip.The pain allegedly got worse on (b)(6) 2014 and he attended a&e.He was asked to return on (b)(6) 2014 for a full x-ray.The x-ray was reported to reveal that the prosthetic component had fractured.The patient was scheduled for surgery on (b)(6) 2014 to have the hip replaced again but on trying to remove the original stem / rod, the femur was reported to have cracked.The patient allegedly had to have a longer stem and also two bands around the femur to strengthen it.The solicitor alleges that the cracking of the femur has resulted in prolonged recovery period, pain and discomfort.

• Brand Name: EXETER V40 STEM 44MM NO 0
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4714841
• MDR Text Key: 5664201
• Report Number: 0002249697-2015-01316
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

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: 05/31/2014
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G2842112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2009
• 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): Hospitalization; Other; Required Intervention