MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-440

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

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

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer reported a spontaneous fracture of the femoral component of thr on (b)(6) 2016 requiring revision surgery on (b)(6) 2016.

Manufacturer Narrative

The device was returned for evaluation.An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed following visual inspection.Method & results: device evaluation and results: visual inspection :visual inspection was performed as part of the material analysis report (mar).The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The review noted the following: damage consistent with the explantation process and cement-mantle breakdown was observed on the stem.Sem analysis was completed on the stem.The location of fracture origin is shown origin is approximately located at or near the prehension hole of the stem.Fatigue striations were observed on the fracture surface, indicating the stem fractured in fatigue.The location of final fracture was noted, with ductile fracture morphologies being observed.This indicates the final fracture occurred in overload.Energy-dispersive spectroscopy (eds) analysis was performed on the stem a continuous metal transfer ring was observed on the taper of the head, indicating proper seating between the stem trunnion and head taper.Based on crack propagation, the head likely fractured due to internal hoop stress.The hip stem fractured.Medical records received and evaluation: a review of the operative report by a clinical consultant concluded, no confirmation of event, need x-rays, clinical past medical history, operative reports.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: fatigue striations were observed on the fracture surface, indicating the stem fractured in fatigue.The location of final fracture was noted, with ductile fracture morphologies being observed.This indicates the final fracture occurred in overload.

Event Description

The customer reported a spontaneous fracture of the femoral component of thr on (b)(4) 2016 requiring revision surgery on (b)(6) 2016.

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: 6118508
• MDR Text Key: 60574409
• Report Number: 0002249697-2016-03739
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

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: 09/30/2013
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G2627902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2008
• 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
• Patient Age: 65 YR