MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOWED CONICAL STEM 15 X 195MM RESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-7-215

Device Problems Break (1069); Fracture (1260); Off-Label Use (1494); Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Information (3190)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

One restoration modular stem has been broken.

Manufacturer Narrative

An event regarding crack/fracture involving a restoration modular stem was reported.This was confirmed following material analysis and a review by a clinical consultant.Stem subsidence was also confirmed.Method & results: device evaluation and results: a visual inspection was performed as part of the material analysis report.It noted: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The stem fractured approximately 5 inches from the distal tip.The material analysis concluded that: the device fractured in fatigue.The fracture initiated at or near the location of laser marking on the stem.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review by a clinical consultant noted: the x-ray shows the medial contact between body and calcar bone was missing while a trochanteric pseudoarthrosis caused lack of bone support on the lateral side.As a consequence, the entire rm body was deficient in bone contact leaving all the stress on the relative thin distal stem section that is not designed to carry major loads for any length of time.The fatigue nature of the fracture was confirmed in the mar where additionally no materials and/or manufacturing defects were observed, all consistent with the radiological findings and the failure mode present because the principal problem to lead to fatigue fracture relates to suboptimal component choice and suboptimal reconstruction of proximal bone defects, failure mode is procedure-related in type.No indications for presence of device-related matters as also confirmed by the mar and in conclusion this pi case is not device-related.- 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: choice for distal cement less fixation with devices not suitable for that purpose and lack of proximal device bone support have caused an overload condition in the device ultimately ending in a fatigue fracture requiring a second revision.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

One restoration modular stem has been broken.

• Brand Name: BOWED CONICAL STEM 15 X 195MM RESTORATION MODULAR HIP SYSTEM
• 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: 5563430
• MDR Text Key: 42319207
• Report Number: 0002249697-2016-01131
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

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: 03/30/2018
• Device Catalogue Number: 6276-7-215
• Device Lot Number: CAXNA39E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2013
• 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
• Patient Weight: 96