MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LFIT MORSE TAPER HEAD; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 01-2200

Device Problems Corroded (1131); Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is during revision surgery.Attempted to remove the head, but i could not take it off.Therefore, the stem itself became loose due to hitting the head in order to remove it.

Event Description

This is during revision surgery.Attempted to remove the head, but i could not take it off.Therefore, the stem itself became loose due to hitting the head in order to remove it.

Manufacturer Narrative

Corrected data: returned to manufacturer on; device evaluated by mfg.An event regarding cup loosening involving a metal head was reported.The event of corrosion was confirmed through mar.Method & results: -device evaluation and results: a material analysis was performed and concluded that "the hip stem was observed to have scratches, adhered debris, explantation damage, and biological fixation.The femoral head was observed to have explantation damage and adhered debris in the female taper.Eds showed that the hip stem was consistent with astm f136 and the femoral head was consistent with astm f1537.The adhered debris on the hip stem was consistent with biological material, corrosion product and metal transfer from the femoral head.The adhered debris on the femoral head was consistent with a corrosion product, biological material and metal transfer.Based on the given information, no identifiable material discrepancies were observed on the surfaces examined." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: it was reported that patients' had a revision surgery due to loosening of cup.A material analysis confirmed the corrosion as an adhered debris observed on the femoral head was consistent with a corrosion product, biological material and metal transfer.Based on the given information, no identifiable material discrepancies were observed on the surfaces examined.Further information such as pre and post-operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

• Brand Name: LFIT MORSE TAPER HEAD
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7152953
• MDR Text Key: 96002337
• Report Number: 0002249697-2017-03759
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K993601
• 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: 03/01/2018

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 Catalogue Number: 01-2200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention