MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM; PLATE, FIXATION, BONE

Catalog Number 627644

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

The reported incident that distal lateral femur plate axsos 3 ti for right femur 14 hole / l310mm was alleged of issue, device deformed could be confirmed.The clinical expert evaluation revealed that the submitted x-rays show orif an unstable comminuted distal peri-implant femoral shaft fracture close to the tip of a pfn (synthes proximal femoral nail).Internal fixation with an axsos distal femur plate (or with a similar anatomically pre-shaped locking plate made by competitors of stryker) is state of the art in such a fractures, particularly in cases with extension near to the knee joint.Therefore, the indication and the surgical procedure have to be estimated as absolutely correct.But, the postoperative x-ray clearly shows an extended comminuted area with insufficient bone support particularly at the medial side which indicates a deficient medial pillar.This implies an absolutely poor constellation for the inserted lateral plate because nearly all forces and bending moments are transmitted by the plate without any sufficient support by medial bone-to bone contact.Due to material fatigue plate fixation is temporary to achieve bone consolidation in general.In the time of bone healing a stringent partial weight bearing has to be ordered to the patient until adequate bone consolidation is observed in the follow up x-rays.It is absolutely normal and well known to an expert that in the case of a deficient medial pillar a plate is not suitable to stabilize a bone for a longer time and will bend and/or break by all means in the case of long term overloading, particularly in the case of delayed union or non-union.In the given case, no particular information on the amount of postoperative weight bearing ordered by the attending physician has been given and there is no information concerning the compliance and the real postoperative weight bearing of the patient.But, the early massive bending of the plate approx.2 months after insertion clearly indicates a significant overloading.Based on the investigation, the root cause was attributed to a patient related issue.The given case clearly presents a typical bending of an internal fixation plate due to overloading in an unstable fracture constellation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of 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.Patient kept the device.

Event Description

It is reported by the surgeon of the hospital, that the angular stable plate was bent at the femoral shaft after stress.Revision surgery was on (b)(6) 2016 with a new nail and plate.

Manufacturer Narrative

The reported incident that distal lateral femur plate axsos 3 ti for right femur 14 hole / l310mm was allegedly deformed, could be confirmed.The clinical expert evaluation revealed that the submitted x-rays show orif an unstable comminuted distal peri-implant femoral shaft fracture close to the tip of a pfn (synthes proximal femoral nail).Internal fixation with an axsos distal femur plate (or with a similar anatomically pre-shaped locking plate made by competitors of stryker) is state of the art in such a fractures, particularly in cases with extension near to the knee joint.Therefore, the indication and the surgical procedure have to be estimated as absolutely correct.But, the postoperative x-ray clearly shows an extended comminuted area with insufficient bone support particularly at the medial side which indicates a deficient medial pillar.This implies an absolutely poor constellation for the inserted lateral plate because nearly all forces and bending moments are transmitted by the plate without any sufficient support by medial bone-to bone contact.Due to material fatigue plate fixation is temporary to achieve bone consolidation in general.In the time of bone healing a stringent partial weight bearing has to be ordered to the patient until adequate bone consolidation is observed in the follow up x-rays.It is absolutely normal and well known to an expert that in the case of a deficient medial pillar a plate is not suitable to stabilize a bone for a longer time and will bend and/or break by all means in the case of long term overloading, particularly in the case of delayed union or non-union.In the given case, no particular information on the amount of postoperative weight bearing ordered by the attending physician has been given and there is no information concerning the compliance and the real postoperative weight bearing of the patient.But, the early massive bending of the plate approx.2 months after insertion clearly indicates a significant overloading.Based on the investigation, the root cause was attributed to a patient related issue.The given case clearly presents a typical bending of an internal fixation plate due to overloading in an unstable fracture constellation.Note, as stated in the ifu v15013: ¿these devices are intended only to assist healing and are not intended to replace normal bone structures.No fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone.The fracture fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.The implantation affects the patient¿s ability to carry loads and her/his mobility and general living circumstances.For this reason, the surgeon must counsel each patient individually on correct behavior and activity after the implantation.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.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 Description

It is reported by the surgeon of the hospital, that the angular stable plate was bent at the femoral shaft after stress.Revision surgery was on (b)(6) 2016 with a new nail and plate.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 14 HOLE / L310MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5619914
• MDR Text Key: 44036528
• Report Number: 0008031020-2016-00219
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K123964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 627644
• Device Lot Number: R32422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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