MAUDE Adverse Event Report: STRYKER GMBH STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 4 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	597024S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Product disposition unknown.
Event or Problem Description
On (b)(6) 2016, the subject fell at home sustaining a femur neck fracture of the left hip.Subject was admitted to hospital.Radiographs showed failure of fixation for right hip fracture.Subject underwent right hemiarthroplasty on (b)(6) 2015 with sliding hip screw fixation.Subject has not been discharged from the hospital.Additional information received, "the broken device currently remains in situ.It has not been decided yet what exactly will happen to the broken device.The patient is expected to make a full recovery and will be discharged home shortly.It was felt prudent not to try and do anything actively with the broken device until the recent hip surgery has healed properly.If the patient is not in pain then it may be that the broken device remains in situ ¿it does depend on the patient.She will be reviewed in outpatient clinic in six weeks when a decision may be made about what to do with the broken device.".
Additional Manufacturer Narrative
The reported event that upon admission to the hospital the patient showed failure of fixation of the device after a fall could be confirmed.The x-rays provided show that the right hip has a backout plate with 3 broken screws, plus a back out screw.The additional screw (lag screw) seems to be in place, despite the plate displacement and the obvious non-union of the fracture.This was confirmed by the clinical expert statement which said: ¿the x-rays show a manifest trochanteric non-union with no signs of bone consolidation.Screws # 1, # 3, and # 4 are broken, screw # 2 is backed out, resulting in varus collapse of the fragments.The images show a typical fatigue implant breakage in a non-union which is rated as normal in after one year of weight bearing and missing bone consolidation.Bone screws from the stryker sps system, which are used for fixation of the omega system, are not intended for long term (12 months) weight bearing in the case of non-union.¿ based on investigation, the root cause was attributed to be patient related.The failure was either caused by the patient fall and/or by the prolonged stay of the implant in the bone.The patient fall is the most likely root cause for the implant breakage, although the fact that the implant stayed in the patient for more than the recommended time can lead to breakage.Note, as stated in the ifu (v15013): ¿4.3 post-operative ¿ post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.¿ the implant intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.[¿] 6 adverse effects in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: ¿ delayed union or non-union of the fracture site.¿ these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ [original statement(s)] a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
On (b)(6) 2016, the subject fell at home sustaining a femur neck fracture of the left hip.Subject was admitted to hospital.Radiographs showed failure of fixation for right hip fracture.Subject underwent right hemiarthroplasty on (b)(6) 2015 with sliding hip screw fixation.Subject has not been discharged from the hospital.Additional information received, "the broken device currently remains in situ.It has not been decided yet what exactly will happen to the broken device.The patient is expected to make a full recovery and will be discharged home shortly.It was felt prudent not to try and do anything actively with the broken device until the recent hip surgery has healed properly.If the patient is not in pain then it may be that the broken device remains in situ ¿it does depend on the patient.She will be reviewed in outpatient clinic in six weeks when a decision may be made about what to do with the broken device.".

• Brand Name: STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 4 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6185583
• Report Number: 0008031020-2016-00628
• Device Sequence Number: 720887
• Product Code: KTT
• UDI-Device Identifier: 07613154325085
• UDI-Public: (01)07613154325085(17)200731(10)J27331
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K062066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 597024S
• Device Lot Number: J27331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 62