MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY SECUR-FIT PLUS MAX #8/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6054-0814S

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Doctor examined a patient for a 10-year follow up.The patient has bilateral total hip arthroplasties.The xray¿s of the patient revealed fractures in the distal flutes of both implanted securfit plus max stems.The doctor has not suggested replacement of the devices at this time.This event is for the left hip.

Event Description

Doctor examined a patient for a 10-year follow up.The patient has bilateral total hip arthroplasties.The xray¿s of the patient revealed fractures in the distal flutes of both implanted securfit plus max stems.The doctor has not suggested replacement of the devices at this time.This event is for the left hip.

Manufacturer Narrative

Corrected data: age at time of event.An event regarding fractures in the distal flutes (crack/fracture) involving a securfit stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿the primary harm involved is mechanical failure of tha hip stems 10 years post implantation.No clinical outcome information is available other than that no corrective action was undertaken as a result of these failures.A single ap xray demonstrates that despite the fractures of the flutes noted both stems appear to be now well fixed ¿ albeit with the right stem in a subsided suboptimal position.¿ ¿the mechanical failures of these two stems appears to have been caused by undersizing of the implants at the time of implantation.In reviewing the xray both femurs demonstrate localized stem fixation and bony hypertrophy at the transitional region of the implant where the coated proximal body and the distal stem come together.This finding is consistent with a of lack of proximal loading or distal fixation of the implant.The most likely cause for this would be undersizing of the implant at the time of implantation.Undersizing would prevent initial primary mechanical fixation and support for the stem as well as abnormal stress distribution, repetitive micromotion and ultimately to fatigue fracture of the fluted distal stem.¿ -product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the reported event of fractures in the distal flutes of the implanted securfit plus max stems was confirmed.The clinician¿s review stated, ¿a single ap xray demonstrates that despite the fractures of the flutes noted both stems appear to be now well fixed ¿ albeit with the right stem in a subsided suboptimal position.¿ as noted in the clinicians review, the alleged root cause may have been caused by the under sizing of the implants at the time of implantation.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PRIMARY SECUR-FIT PLUS MAX #8/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7175009
• MDR Text Key: 96734224
• Report Number: 0002249697-2018-00089
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K051738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2012
• Device Catalogue Number: 6054-0814S
• Device Lot Number: 15HMDD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR