MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-442

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

Patient Problems Bone Fracture(s) (1870); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 07/16/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The patient felt his left hip snap when he moved on the toilet.He has not been able to support the leg since the incident.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed following visual inspection.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), the report noted: the medial surface of the distal stem has damage being observed.This damage is consistent with cement-mantle breakdown.Explanation damage was also observed on the stem and head.A material analysis has been performed.The report concluded: the stem fractured due to fatigue.Eds showed the stem was consistent astm f1586 alloy.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review by a clinical consultant noted: brooker grade 3 or 4 calcifications may cause stiffness with reduction in range of motion in the hip and if the hip joint itself becomes less compliant, attempts at bending in the hip joint will cause higher bending stresses in the proximal section of the stem or neck.[.]this causes fatigue to build up over time with finally after 8-years a fatigue fracture exactly at the level of peak overload.This adverse biomechanical effect of the calcified mass in the hip joint appears to be the principal contributing factor to failure.Device history review: all devices in the reported lot 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: a review by a clinical consultant concluded: heterotopic ossifications in the hip joint space have caused limitation in hip movement causing bony impingement related adverse effects.This caused an overload condition in the bearing area with fatigue build-up and finally a fatigue fracture exactly at the level of peak overload.If additional information becomes available, this investigation will be reopened.

Event Description

The patient felt his left hip snap when he moved on the toilet.He has not been able to support the leg since the incident.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5879786
• MDR Text Key: 52231278
• Report Number: 0002249697-2016-02626
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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 Expiration Date: 09/30/2014
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G2919712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2009
• 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; Required Intervention