MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-128

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); Injury (2348); Joint Dislocation (2374)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that surgeon revised a gmrs proximal femur with trident constrained liner which appeared to have dislocated on the x-ray.Surgeon said the patient was sitting on a very low stool and leaned forward and felt immediately very uncomfortable.Upon inspection, surgeon said the bipolar head had disassociated from the trident insert.He said he did not know how this was possible.He replaced the constrained insert size f with a new constrained liner and replaced the 40mm extension piece with a 50mm extension piece.He replaced the 28mm standard +0 head with a -4mm 28mm head.

Manufacturer Narrative

An event regarding disassociation involving a metal head was reported.The event was confirmed.Device evaluation and results: material analysis was performed and concluded that "debris was observed on the taper of the v40 head and gmrs extension piece.Impingement was observed on the distal rim of the constrained insert.Debris consistent with the decontamination process was observed on the v40 head.Debris consistent with a corrosion product and biological material was observed on the gmrs extension piece.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the medical records by the clinician indicated "the primary harm involved is dissociation of a femoral head from a constrained tha acetabular liner in a patient who had a proximal femoral replacement.There is insufficient documentation presented to complete this assessment in detail however there is mention in one of the nursing records of sarcoma.This could explain the need for a proximal femoral replacing tha (gmrs) following a resection of the patient¿s proximal femur as an index surgery ( date unknown).In april 2014 he underwent a revision of this tha due to fracture of his ceramic femoral head.He then underwent further revisions including the head/liner dissociation which is the object of this assessment.Stability of this type of tha is completely dependent on the mechanical interlock of the constrained liner around the femoral head.Material analysis demonstrated impingement on the distal rim of the constrained insert most likely from the femoral neck.Without the stabilizing effect of the surrounding soft tissues lost during the femoral resection the interlock was overcome leading to dissociation and dislocation.Although no information is provided similar factors may have led to the ceramic head fracture.No material or manufacturing defects were observed." device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.The exact cause of the reported event could not be determined because insufficient information was provided.Additional information, including outpatient office/clinic notes, operative reports, surgical pathology reports and pre and post op xrays from the index and revision surgeries are needed to complete the investigation for determining root cause.

Event Description

It was reported that surgeon revised a gmrs proximal femur with trident constrained liner which appeared to have dislocated on the x-ray.Surgeon said the patient was sitting on a very low stool and leant forward and felt immediately very uncomfortable.Upon inspection, surgeon said the bipolar head had disassociated from the trident insert.He said he did not know how this was possible.He replaced the constrained insert size f with a new constrained liner and replaced the 40mm extension piece with a 50mm extension piece.He replaced the 28mm standard +0 head with a -4mm 28mm head.

• Brand Name: 28MM STD LFIT V40 HEAD
• 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: 5534475
• MDR Text Key: 41458765
• Report Number: 0002249697-2016-01012
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/07/2016

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: 05/31/2018
• Device Catalogue Number: 6260-9-128
• Device Lot Number: 43606904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2013
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 88